IPED2015CS01 MAC049 PIS&ICF 4.0 Part A and B (18dec2018) - Final Version

MAC CLINICAL RESEARCH
Neuroscience Centre Of Excellence, MAC Clinical Research, Citylabs,

Nelson Street, Manchester M13 9NQ, United Kingdom
Tel: +44 (0) 161 275 9966; Fax: +44 (0) 161 2745403; www.researchforyou.co.uk
Participant Information Sheet

(Part A and B)
CONFIDENTIAL
Study Title: A Phase I, Randomised, Double-Blind, Placebo-Controlled,

Ascending Single Oral Dose, Safety, Tolerability, Pharmacokinetic and
Pharmacodynamic Study of IPED2015 in Healthy Male Subjects and Healthy
Elderly Male Subjects (Part A and B). A Phase II, Randomised, Placebo-
Controlled, Double-Blind, Crossover Study, Investigating the Effects of a Single
Dose of IPED2015 on Erectile Function in Males with Erectile Dysfunction
(Part C).
Sponsor: Initiator Pharma
Lyngsiesvej 18
Åbyhøj
Denmark
Protocol Number: IPED2015CS01
MAC Number: MAC049
Principal Investigator: Dr. Peter Dewland
Study Site: MAC Clinical Research
Citylabs
Nelson Street
Manchester
M13 9NQ
United Kingdom
INTRODUCTION
You have been invited to take part in a research study that will test a drug that has not
been given to humans before and is not yet licenced or approved. This study will be
the first time this drug will be given to humans. The study is organised and funded by
Initiator Pharma (the ‘Sponsor’) and will be run by MAC Clinical Research.
Before you decide, you need to understand why the research is being done, what it
would involve for you, how your information will be used and the possible benefits,
risks and discomforts. The study doctor or one of their team will go through this
information sheet with you and answer any questions you may have. This process is
called ‘informed consent’.
Final V4.0 Part A and B (18 December 2018)

Patient Information Sheet/Informed Consent - Initiator Pharma REC Approval Date: 27Sep2018
MAC Issue Date: 20Dec2018
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Please take time to read the following information carefully. You may talk to your own
family doctor or family/relatives/friends about the study, if you wish.
Part 1 - tells you the purpose of this study and what will happen to you if you
take part.
Part 2 - gives you more detailed information about the conduct of the study.
Please ask us if there is anything that is not clear.
This information sheet may contain words you do not understand. Please ask the study
doctor or study staff to explain any words or information that you do not clearly
understand or if you would like more information.

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Part 1
WHAT IS CLINICAL RESEARCH?

Clinical research projects are performed as a way of bringing about progress in
medicine and research. Clinical research projects make it possible to scientifically
assess the properties of a drug, to demonstrate the effectiveness and safety of a
treatment, or to learn more about a disease and methods to diagnose and monitor it.
WHAT IS THE PURPOSE OF THIS STUDY?
The purpose of this study is to test a drug called IPED2015 (the ‘study drug’) that is
being developed for the treatment of erectile dysfunction (ED). Erectile dysfunction is
the term used to describe when a man is unable to develop or sustain an erection,
which can lead to difficulties in having sexual intercourse. The drugs that are currently
available to treat ED work by relaxing the blood vessels in the penis, so more blood
can flow through the penis to produce an erection. Although these drugs are effective
in treating the condition in some men, approximately 30% to 40% of them do not
respond to this treatment. The study drug is a new compound which works in a
different way by enhancing the effects of substances in the body such as dopamine to
help stimulate an erection. The study drug is being developed in the hope that it will
treat men in whom current treatments for ED do not work.
The main aims of this study are:
• To assess the safety and tolerability of the study drug
• To see how the body absorbs and removes the study drug
• To assess the effect of the study drug on the body
You do not have to have ED to take part in this study. This study will be divided into 3
parts (Part A, Part B, and Part C). This participant information sheet and consent
form will cover Part A and Part B only. Part A will be the first time the study drug
will be given to humans. The study drug has been tested extensively in animals at
doses higher than will be tested here and it was found to be safe and well tolerated.
Part B will start once Part A has been completed.
During this study, you will either be administered 1 dose of study drug or 1 dose of
placebo. A placebo is a substance that looks like the study drug but does not contain
the active ingredient. Both you and the study doctor will not know whether you receive
the study drug or placebo. It will be randomly determined (by chance, like flipping a
coin) which treatment (study drug or placebo) you will receive. However, if a medical
emergency occurs during the study that requires knowledge of the treatment assigned
to you, your study doctor will be able to quickly find out what treatment you have been
allocated.
During Part A, 58 participants will be divided into 8 groups. The first 2 of these groups
will have 5 participants per group (Group 1 and Group 2). Of these 5 participants, 3
will receive the study drug and 2 participants will receive placebo. The remaining 6
groups will have 8 participants per group (Group 3, 4, 5, 6, 7 and 8). During Part B, 8
participants will be in 1 group only. In Group 3, 4, 5, 6, 7 and 8 in Part A and the 1

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group in Part B, 6 participants will receive study drug and 2 participants will receive
placebo; that is, a 1 in 4 chance of receiving placebo.
Part A Only
During Part A only, in each of the 8 groups, 2 subjects will be dosed first as the
‘sentinel’ group, approximately 24 hours later, the rest of the group will be dosed. In
Groups 3 to 8 only, following the sentinel participants, the remaining 6 participants will
be dosed in subgroups (a maximum of 4 participants per subgroup), such that one
subgroup will be dosed first, and the next subgroup of will be dosed a minimum of 24
hours later.
The first group of 5 participants (Group 1) will receive a dose of 0.01 mg of the study
drug, and the second group of 5 participants (Group 2) will receive a maximum dose
of 0.05 mg of the study drug. The third group of 8 participants (Group 3) will receive a
maximum dose of 0.2 mg of study drug. After each group of participants are dosed,
the study drug data will be reviewed by a safety committee before the next group of
subjects is dosed, if thought safe to do so. The doses that are received by the
remaining 5 groups of 8 participants (Group 4, 5, 6, 7 and 8) will be decided based on
the study drug data from the first 3 groups and subsequent groups, however the
highest dose administered during this study will not exceed 20 mg, which is well below
the dose which caused any side effects in animals. You will be informed of the dose
you will receive prior to study drug administration.
Part B Only
During Part B only, the dose of the study drug you will receive will be decided based
upon the study drug data from Part A. However, this dose will not exceed the highest
dose administered in Part A.
The study drug is ‘investigational’, which means that it has not yet been approved for
marketing by the Medicines and Healthcare Products Regulatory Agency (MHRA) in
the UK, or the Food and Drug Administration (FDA) in the USA.
The information about you will be kept anonymous. Information may be used in reports
of the study or for scientific presentations. The Sponsor may also use the information
from this study for future medical research.
WHY HAVE I BEEN INVITED TO PARTICIPATE?
You have been invited to take part in this study because you are a healthy male.
Moreover, you are likely to match all the other characteristics required to enter the
study. This study will be divided into 2 parts. Part A will be conducted in 58 healthy
male participants aged between 18 to 59 years of age, split into 6 groups of 8
participants per group. Part B will be conducted in 8 healthy elderly male subjects aged
between 60 to 80 years of age, in 1 group. The study assessments and visits will be
the same for both Part A and Part B.
For each group of participants, reserve participants will be screened and available to
replace participants on the day of dosing (Day 1), if needed.

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DO I HAVE TO TAKE PART?

No, it is your choice whether to take part in this study. You should not feel pressurised.
You do not have to decide today whether or not you will participate. You are free to
leave and think about taking part. You may also discuss it with your own family doctor
or family/relatives/friends if you wish to do so. You may stop taking part at any time
during the study. You do not have to give a reason why. This will not affect your regular
medical treatment from your doctor.
WHAT WILL HAPPEN TO ME IF I TAKE PART?
Your participation in this study will last approximately 5 weeks and you will be required
to attend for study visits on 3 occasions in total, consisting of a screening visit, an
inpatient visit (4-day period) and a follow-up visit. The visits will take place at the MAC
Clinical Research Unit located at Manchester.
The schedule of events is in the table below and a detailed description of these
assessments is provided further below.
Schedule of Events
Visit 1 Visit 2 (Inpatient Stay) Visit 3
Screening Follow-up Visit
Day -28 to Day -1 Day 1 Day 2 Day 3 5 to 7 Days
Day -2 After Visit 2
Procedures and Assessments
Inclusion/Exclusion X X
Criteria
Demographic data X
Medical history X
Drugs of abuse screen X X
Alcohol breath test X X
Serology X
IIEF-5 Questionnaire X
Study Drug X
Administration
Adverse event X X X X
questions
Vital signs (blood X X X X X
pressure, heart rate
and oral temperature)
12-Lead ECG X X X X X
Clinical laboratory X X X X X X
evaluations
Physical examination X X X
Continuous cardiac X X X
monitoring
Rigiscan X X
measurements
CNS assessments X
Prolactin sampling X X X
Blood sampling X X X
Urine collection X X X
A summary of the study and assessments at each study visit is shown in Figure 1.

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Figure 1
A detailed description of the visits, and assessments conducted during the visits, are
described below.
Visit 1 Screening (Day -28 to Day -2) Part A and B
Details The visit will last approximately 3 hours. This visit can occur up to 27 days before
Visit 2.
If you want to take part in the study and you have given your written informed consent,
several screening assessments will be performed by your study doctor and the staff.
These screening assessments at the beginning of the study are done to see if you are
eligible and safe to be included in the study. Further details are provided below.
Screening
Procedures • Provide written informed consent.
• Social questions – asking about age, sex, ethnic origin (demographic data).
• Medical history (asking about current or previous illnesses and any previous
medications taken).
• Drugs of abuse test - your urine will be collected and tested for the use of opioids
(medications used for pain relief), cannabis-like substances and other drugs of
abuse as the use of these substances can influence the effect of the study
treatments and put you in danger.
• Alcohol breath test
• International Index of Erectile Function (IIEF-5) Questionnaire – this questionnaire
will contain questions about your erectile function. You will be asked to fill in this
questionnaire and the answers will be reviewed by a study doctor.

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• Blood and urine testing (clinical laboratory evaluations) including tests to check
your liver and kidneys and other body systems are working normally. Your samples
(from which your identity cannot be directly determined) will be transferred to The
Doctors Laboratory (TDL) for analyses such as the numbers of red and white blood
cells as well as several liver and kidney function tests. The results will be available
within a few days and your study doctor will inform you if any abnormalities are
found.
• Checks for human immunodeficiency virus (HIV) and hepatitis B and C. It is
important to know if you have been exposed to some specific viruses; for this
reason, serology screening tests will be performed, which will be a test to find out
whether you have been exposed to the HIV virus, hepatitis B or hepatitis C. All of
this information will be confidential, and no other person or body will be informed
about the test results unless this is explicitly requested, and permission is given by
you. If the test does not identify any exposure to the HIV virus, hepatitis B or
hepatitis C you will continue the screening process as usual. If the test shows
evidence of exposure to the HIV virus, hepatitis B or hepatitis C, you will not be
able to continue with the screening process and you will be invited to meet our
doctor. During this meeting with our doctor, you will be advised to seek counselling
and follow-up at the Sexual Health Clinic of the Manchester Foundation Trust, or a
Sexual Health Clinic convenient to your location, where the test will be repeated.
We can help you arrange this but it is entirely up to you to avail yourself to this offer.
If you decline to do so, this will be documented and kept confidential. It is important
to let the Sexual Health Clinic know about the test result in order to get the
necessary ongoing care. If you choose for any reason not to follow-up with the
Sexual Health Clinic about the test results, it may still become necessary for us to
inform them as you could potentially be putting others’ health at risk. Again, you
will be informed about this before doing so and a record will be maintained.
• Blood pressure, oral body temperature and heart rate measurements (vital signs)
will be measured when you are standing and lying down.
• Recording of the electrical activity of your heart (ECG). The ECG is painless and
looks at how your heart is beating and checks for any irregularities. Ten stickers
with wires are temporarily applied to your chest, arms and legs and the electricity
linked to heart beats can be detected. You may be asked to shave your chest.
ECG will be done several times in a row to collect information to average. The ECG
may be repeated for clarification purposes if any irregularities are observed.
• Physical examination (a medical check-up by the study doctor) including height and
weight and examination of your genitals.
• Your GP will be informed of your participation in this study. Your GP will also be
contacted (with your permission) and asked to supply your medical history.
Additional After your screening visit, a doctor will look at the results of all these tests and then
Information decide if it is okay for you to take part in the Study. If it is, you will be asked to return
to the Unit for Visit 2.
It is possible that you cannot participate in this study due to results from questions or
tests performed during the screening assessment. This may not mean you are
unhealthy, just that some of the findings make you less suitable for this particular
study.

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Visit 2 Inpatient Visit (Day -1 to Day 3) Part A and B

Details The visit will last approximately 4 days.
Further details of the assessments conducted during this visit are provided below.
Study
Procedures • Drugs of abuse test (Day -1)
• Alcohol breath test (Day -1)
• Physical examination including examination of your genitals (Day -1).
• Blood and urine testing including tests to check your liver and kidneys and other
body systems are working normally (Day -1 to Day 3).
• Recording of the electrical activity of your heart (ECG) at specific times. ECG will
be done several times in a row to collect information to average (Day 1 to Day 3)
• Continuous ECG recording for a minimum of 44 hours. You will be asked to wear
a small transmitter wired to chest connectors (morning of Day -1 until morning
of Day 2).
• Oral administration of the study drug or placebo by drinking a solution (Day 1).
• Questions about your health and medications you have taken (Day 1 to Day 3).
• Vital signs will be measured when you are standing and lying down (Day 1 to
Day 3).
• Rigiscan assessment (Day -1 and Day 1; This will occur in Groups 3 to 8 only
in Part A and in all participants in Part B) – a Rigiscan is a monitor used to
measure the activity of the penis in different ways. The Rigiscan monitor consists
of 2 loops, one that is placed around the base of the penis and one that is placed
towards the tip. These loops tighten gently every 15 to 30 seconds. The data
collected from these loops will be stored on a recording unit that will be strapped
around your thigh. You will be asked to self-apply this monitor and the study staff
will instruct you how to do this. You will need to bring loose-fitting clothing to the
Unit to wear during this assessment (further information about the Rigiscan monitor
is provided in the section ‘What do I have to do to participate in the study?’
below).
• Central nervous system (CNS) assessment (Day 1) – the CNS assessments will
consist of the following tests:
o a test to measure your eye movement (this will occur in Groups 3 to 8 only in
Part A and in all participants in Part B).
o a test to measure any symptoms you may be having.
• Blood sample to measure for a hormone called prolactin (Day -1, Day 2 and Day 3)
• Blood samples to measure levels of study drug - if considered necessary, a cannula
(small plastic tube inserted into a vein in your forearm using a needle) may be used
for repeated blood sampling and will be removed after approximately 24 hours
(Day 1 to Day 3). Thereafter any samples will be taken by venepuncture (inserting
a needle directly into a vein).
• Urine samples to measure levels of study drug - You will collect all your urine into
bottles, no urine will be allowed to pass into the toilet on study days (Day 1 to
Day 3).
Additional While staying in the unit all meals and drinks will be provided for you. Additional drugs
Information of abuse and alcohol breath tests may be carried out randomly throughout the study.
You will be asked to fast (not eat and drink anything except water) overnight before
administration of the study drug, until 4 hours after. Water will be allowed freely except
for 1 hour before and 1 hour after the drug has been administered. The study drug will

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be administered with approximately 240 mL of room temperature water, which you will
be required to drink.
At the end of the study period, provided you are well and all your test results are
appropriate, you may go home. If a doctor thinks it is necessary, you may be asked
to remain in the Unit for further observation until any symptoms or test results have
returned to normal.
Visit 3 Follow-up Visit (5 to 7 Days After Visit 2) Part A and B

Details This visit will occur 5-7 days after the end of Visit 2.
The visit will last approximately 2 hours.
Study
Procedures • Physical examination
• Blood and urine testing including tests to check your liver and kidneys and other
body systems are working normally.
• Recording of the electrical activity of your heart (ECG).
• Vital signs will be measured when you are standing and lying down
• Questions about your health and medicines you have taken.
Additional If your blood and urine test results are abnormal, you may be requested to attend for
Information additional visits for blood and urine tests until these return to normal.
If you do not complete the study these assessments may also be performed at the
point of withdrawal.
Samples
During this study, an approximate blood volume of 132 mL will be taken from you
during the course of the study (approximately 23 teaspoons).
Reason for Sample Type of What Will Happen to the

Sample Sample?
Sample to measure levels of the study drug. Blood/ Your samples (from which
This sample will be taken to measure the Urine your identity cannot be
amount of drug in the body. directly determined) will be
transferred to a local
laboratory for analyses.
Your samples will be kept
for a maximum of 18
months.
Sample for clinical laboratory evaluations. Blood/ Your samples (from which
This sample will be taken to check you are Urine your identity cannot be
healthy. directly determined) will be
transferred to a local
laboratory for analyses.
Your samples will be kept
for approximately 3 months.
Medications
During every visit your study doctor or a member of the clinical team will ask you
whether you have taken any medications since the last visit. Certain medications are

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allowed during the study, e.g. paracetamol (up to 2 g/day) for headaches up to 48
hours before dosing with the study drug. Other treatments are not allowed, as they
may affect your safety or the interpretation of the study results. Your study doctor will
check this and will explain what is allowed and what is not allowed.
General condition and complaints
On each visit you will be asked about your general condition and any complaints you
might experience (for example possible side effects of the study medication). If your
complaints warrant further investigation, additional tests will be done and additional
visits (so called “unscheduled visits”) might also be planned by your study doctor.
Please report all unusual experiences, since they may be important.
If you decide to withdraw before the scheduled end of the study, you will be requested
to return to the Unit for a Follow-up visit for final study assessments to be carried out.
WHAT DO I HAVE TO DO IF I PARTICIPATE IN THE STUDY?
Use of the Rigiscan monitor (Groups 3 to 8 only in Part A and all participants in
Part B)
During the study, if you are in Groups 3 to 8 in Part A, or are a participant in Part B
you will be asked to self-apply the Rigiscan monitor as shown in Figure 2 and Figure 3.
Figure 2 Figure 3
The Unit staff will instruct you how to do this properly, in addition to explaining any
restrictions during this assessment. The Rigiscan monitor is normally worn for 10
hours at a time, however during this study you will have to wear the Rigiscan monitor
for a period of 12 hours for research purposes.

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Previous Medical History

You must tell your study doctors and staff everything about your health history in an
open and honest manner.
Use of other medications
Please inform your study doctor about all the medications that you take, including
herbal preparations and even those that you buy without a prescription (over-the-
counter). In particular, any previous or current medication taken for ED should be
communicated to the study doctor. You may not be suitable to take part in the study if
you use certain medications. If you are suitable to participate, you will be asked to
refrain from taking any prescription or over-the-counter medications for a period of 14
days prior to dosing.
Please consult with your study doctor before taking any new medications before or
during the study.
Lifestyle
Please avoid major changes in your exercise, diet and drinking habits during the study.
You must not do strenuous exercise (eg, heavy lifting, weight training, aerobics) for 48
hours prior to each visit, and while in the unit.
Diet
You must refrain from eating any food other than that which is provided to you while
you are in the unit. On the day of dosing (Day 1) you will be fasted (not allowed to eat
or drink anything except water) overnight prior to receiving a dose of the study drug,
until 4 hours after dosing. You must also fast 8 hours before safety blood assessments
(8 hours before Visit 1, 2 and 3). Water will be allowed throughout except for 1 hour
before and 1 hour after dosing. The following are also restricted during the study:
• As poppy seeds can sometimes cause a positive result on the drugs of abuse
test, you should avoid eating poppy seeds/food containing poppy seeds for at
least 48 hours before attending for any drugs of abuse test.
• Grapefruit, grapefruit juice, or Seville oranges for 14 days prior to dosing and
throughout the study until the study is complete.
• Caffeine or caffeine-containing products (eg, tea, coffee and chocolate) for 24
hours prior to each visit until discharge from the unit.
Alcohol
You will be required to refrain from drinking alcohol for 48 hours prior to each visit until
discharge from the unit. You must not drink an excessive amount of alcohol (>21 units
per week e.g. 3 small glasses of wine or 1.5 pints of normal strength beer per day) for
the duration of the study.
Smoking
Only non-smokers will be allowed to take part in the study. You must not have smoked
or used nicotine-containing products within 3 months of screening or during the study.

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Contraception
It is not known if the study drug will affect sperm or semen and therefore you must
agree to use contraception in the form of a male condom from the time of dosing until
90 days afterwards. In addition, if you have a female partner of child-bearing potential,
she must be also be using one of the following forms of highly effective contraception
from 1 week before screening until 90 days after dosing:
• Taking hormonal contraceptives
• Using an intrauterine device (IUD) or intrauterine hormone-releasing system
(IUS)
• Surgical sterilisation
If you have had a vasectomy, this would be an acceptable second form of
contraception (in addition to wearing a condom).
This must be continued for at least 90 days after dosing with the study drug.
Additionally, you must not donate sperm from the time of dosing until 90 days after.
If your female partner does become pregnant during the course of the study, we would
ask you to tell your study doctor immediately, so we can help decide upon appropriate
action. Arrangements will be offered to monitor the health of both your partner and
your unborn baby.
The Sponsor may also request your consent to collect information about your partner’s
health and that of the baby.
Donation of blood or plasma
You must not donate blood or plasma for 4 weeks before dosing, until 4 weeks after.
Study visits
You will be asked to attend all scheduled study visits.
Administration of study medication
Study drug will be administered during the visit on Day 1 (Visit 2).
Illness during study
Throughout the study, you should notify your study doctor of any illnesses, ill effects
or abnormalities you may suffer, whether or not you think they are related to the study.
Also, please tell your study doctor about medication you are taking, either bought by
yourself or on prescription from your own family doctor/general practitioner.
Participation and discontinuation
As explained above, you are free to withdraw your participation in the study at any
time without any consequences for you. In order to help the study produce relevant
and adequate results that will contribute to the development of new treatments, we
ask you to first discuss such an intention with your study doctor. Should you withdraw
from the study then the information may still be processed along with any other data
collected while in the study, but no new data will be added to the database and if you
wish you may ask for your previously retained samples to be destroyed, to prevent
further analysis.

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WHAT ARE THE POSSIBLE DISADVANTAGES AND RISKS OF TAKING PART?

Risks associated with drawing blood
As is common with blood drawing you may feel some discomfort when the needle goes
into your vein. In addition, you may experience light headedness or irritation, such as
redness, tenderness and bruising at the sites used to obtain blood. Having a tube
(cannula) placed in your arm for blood sampling can cause soreness, bruising,
blockage of veins and (rarely) infection. These problems usually clear up within a few
weeks. Blood tests can also make you feel faint, so we’ll get you to lie down when we
take your blood.
Risks associated with ECG and continuous ECG monitoring
An ECG is a completely safe test. You may experience local skin irritations and
redness from the stickers on your skin that will recover quickly.
Risks associated with the Rigiscan monitor (this will only apply if you are in
Groups 3 to 8 in Part A and all participants in Part B)
You will be instructed by Unit staff how to apply the monitor and anything you will be
restricted to do whilst it is applied. If the Rigiscan is used following instructions it should
be safe with no risks. There have been side effects and complications reported
including penile pain, redness, bruising, abrasions (scrapes), or cuts on the penis skin
from the action of the loops that will be on the base and the tip of your penis. Urethral
bleeding (bleeding of the tube that carries the urine) and haematuria (blood in urine)
have also been reported. You will be carefully monitored for any side effects caused
by the Rigiscan monitor. If you are experiencing any complications with the monitor
you can report these to the study doctor and the monitor will be removed.
WHAT ARE THE SIDE EFFECTS OF THE STUDY MEDICATION?
This is a first-in-human study with IPED2015 (the study drug), and side effects of this
drug in humans are not yet known. The study drug has been given to 1 participant so
far and it was noted that there was a brief change in the electrical activity of his heart.
The individual did not report feeling unwell and had no symptoms and did not
experience any further episodes of this. This electrical disturbance could have been
due to an inbuilt problem in this individual or the study drug, or chance. This electrical
disturbance can be serious in some cases and led to the study being temporarily
stopped to thoroughly investigate. The investigations found no obvious problem with
the individual. The study has been restarted at a significantly lower dose with
increased safety measures to reduce any potential risk.
Potential side effects have been identified from the current knowledge about the way
the drug works, the information from the 1 participant dosed so far, and from animal
studies:
• Changes to ECG traces. ECG traces are taken continuously throughout your
stay in the clinical unit. If there are any abnormal changes identified by the study
doctor or clinical team, the study doctor will discuss this with you. This may
mean you may be withdrawn from the study.
• Increase in heart rate and changes to blood pressure could, theoretically, be
seen in drugs of this class, however this wasn’t confirmed in animal studies. If
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either your heart rate or blood pressure changes significantly, the study doctor
will take the appropriate steps to monitor these effects.
• Due to the information available in drugs of this class, there is a risk that it may
be addictive in humans when given as repeated doses, however this was not
seen in animal studies. The study drug will only be given once and at smaller
doses than in animal studies, therefore it is not anticipated to be addictive.
• In animal studies, there were symptoms of overactivity noted which could result
in restlessness or insomnia (difficulty sleeping) in humans, these effects were
not noted at the doses that will be given in this study and you will be carefully
monitored for these side effects throughout the study.
• Feelings of nausea or sickness can sometimes occur following administration
of drugs of this class. You will be carefully monitored for these side effects
throughout the study.
• As the study drug is intended to treat ED, it is anticipated that side effects could
include spontaneous erections as was seen in animal studies. While there are
no risks or pain associated with this, there could be a remote chance that the
study drug could cause priapism, which is a persistent and painful erection of
the penis. You will be monitored for these side effects closely throughout the
study and if this occurs, there are things that the Study Doctor can suggest that
you do to help resolve it without treatment such as:
o having a warm shower,
o drinking lots of water,
o going for a gentle walk,
o trying exercises such as squats or running on the spot.
• If the erection occurs for more than 2 hours you will be transferred to an
emergency unit.
You will be carefully monitored during your time on the study, although this does not
mean these could not happen. As with any drug, side effects that were not previously
described may occur. You may also have an allergic reaction to the study drug. It is
important that you report to your doctor all symptoms and adverse events that you
may experience, as soon as they appear, whether or not you think they are related to
the study drug.
Although all possible precautions are taken to prevent serious adverse events (side
effects), if such a side effect occurs, you may need to be admitted into hospital.
Depending on the type of side effect, a medical specialist may be asked to take over
your care.
WHAT ARE THE POSSIBLE BENEFITS OF TAKING PART?
It is not anticipated that there will be any therapeutic benefit to you, but you are
contributing to the scientific knowledge which may lead to expansion of the treatment
options for people with ED.
This completes Part 1.

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If the information in Part 1 has interested you and you are considering taking part,
please read the additional information in Part 2 before making any decision.

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PART 2
WHAT IF NEW INFORMATION BECOMES AVAILABLE?

During the course of the research project, new information may become available
about the drug that is being studied, which may influence your willingness to continue
to participate in the study. If this happens, your study doctor will tell you about it and
discuss it with you as to whether you wish to continue in the study. You may withdraw
from the study at any time. If you decide to withdraw, your study doctor will discuss
your options with you. If you decide to continue in the study you will be asked to sign
an updated consent form.
Also, on receiving new information, your study doctor might consider it to be in your
best interest to withdraw you from the study. He/she would explain the reasons and
arrange for your care to continue.
You have the right to know if, in the future, anybody plans to do any extra tests on your
samples collected as part of this study. If we wish to undertake tests not mentioned
here then we would contact you for your specific consent.
WHAT WILL HAPPEN IF I DON’T WANT TO CARRY ON WITH THE STUDY?
You can stop taking part in this study at any time.
If you decide to stop being part of the study you should:
• Tell the study doctor immediately
• See the study doctor to be examined
UNDER WHAT CIRCUMSTANCES WOULD I BE WITHDRAWN FROM THE
TRIAL?
Your study doctor can take you out of the study even if you wanted to continue taking
part if:
• The Sponsor, regulatory authority or ethics committee cancels the study
• The study doctor thinks that removing you from the study is in your best
interests
• You need extra medication that would interfere with the study
• This is necessary to meet the requirements of the study
• You are not co-operating or you have not followed the directions given by the
study doctor
If you stop being part of the study for any reason, the study doctor may continue to
use and distribute any information gathered in connection with you taking part in the
study as long as this is for the purposes described in this participant information
sheet/consent form. You may also be asked to cooperate in having whatever
laboratory tests and examinations the doctor thinks necessary.
You can also ask that all samples that are kept which can be identified as coming from
you are destroyed to prevent further analyses.
Page 16 of 24
WHAT IF THERE IS A PROBLEM?

Queries and Concerns
If you have a concern about any aspect of this study, you should ask to speak to a
member of the research team who will do their best to answer your questions (see
contact numbers provided at the end of this sheet).
Harm
If you become ill or injured due to your participation in this study, medical treatment
will be provided as required in accordance with normal standards of medical care. The
Sponsor has taken out study insurance and has agreed to provide compensation for
any injury caused by taking part in this study in accordance with the guidelines of the
Association of the British Pharmaceutical Industry (ABPI). Broadly speaking, the ABPI
guidelines recommend that the Sponsor, without legal commitment, should pay
compensation where the injury probably resulted from:
• A drug being tested or administered as part of the trial protocol
• Any test or procedure you received as part of the trial
The Sponsor would not be bound by these guidelines to pay compensation where:
• The injury resulted from a drug or procedure outside the trial protocol
• The protocol was not followed
Other exceptions and limitations on compensation may also apply. For further
information, copies of the ABPI guidelines are available on request.
The Sponsor does not provide compensation other than that described above. If you
would like more information about compensation for research-related injuries, contact
the study doctor.
DATA PRIVACY AND CONFIDENTIALITY
WHY IS MY DATA BEING COLLECTED?
Your data is being collected by MAC Clinical Research on behalf of the Sponsor. MAC
Clinical Research is a company that conducts clinical trials and processes the trial
data for Sponsors so that they can use this data to develop medicines and further
scientific research. The lawful basis for processing your data is to ensure that MAC
Clinical Research can carry out its legitimate interests, which include the conduct of
clinical trials.
WHAT WILL HAPPEN TO MY DATA DURING THE STUDY?
Your personal details and information from the study are processed by MAC Clinical
Research in accordance with EU data protection law (General Data Protection
Regulation [GDPR] EU 2016/679), which is designed to protect your privacy. Your
identity and other information obtained during this study will be kept confidential.
However, information that does contain your identity may be disclosed in certain
circumstances (see table below). If your data is transferred outside the European

Page 17 of 24
Economic Area (EEA) where this regulation applies, by a Sponsor or Vendor

associated with MAC, it will be contractually agreed between MAC Clinical Research
and the Sponsor/Vendor that the Sponsor will be responsible for ensuring that your
data will be protected in a manner that is consistent with GDPR requirements.
The table below explains what data will be taken from you and what will happen to
your data:
Type of data Who has access? Where can this be
transferred to?
Personal data (for example, MAC Clinical Research Name, date of birth and
name, date of birth, address, employees including address can be transferred to a
passport details, NI numbers, ID, physician, nurses, clinical vendor subcontracted by MAC
photograph). assistants and who needs to perform a
administrators. procedure (eg, X-ray or MRI;
Representatives of medicines MAC Clinical Research ensures
regulatory authorities, this company complies with the
members of ethics requirements of GDPR).
Medical data (medical records). committees that approved the Identifiable medical records will
study or representatives of not be transferred outside of
companies working on the MAC.
Study data (information collected Sponsor’s behalf may inspect This could be transferred to a
from screening onwards) that can the study files and your third-party vendor working on
be used in reports of the study or medical records to ensure the study within or outside of the
for scientific presentation. Your that the results of the study EEA. The Sponsor may also
personal details will be kept have been properly recorded. wish to use the information from
anonymous. this study as anonymous data
Vendors working under for future medical research into
contract to MAC in order to as yet undefined scientific
provide services such as x- issues.
rays or MRI scans.
Your data may be stored for 15 years or more after the study has been completed,
according to regulatory requirements. You will have the right to access and control the
use of your medical records, together with your doctor, as allowed by national law.
However, the study treatment will need to remain unknown until the study data
analysis is completed.
You can obtain information on which treatment you have received after analysis and
reporting of the study results. However, to ensure scientific integrity of the study, you
agree that you may not be able to obtain this information until after the study has been
completed. This may be many months after you have finished the study.
If you have any concerns or questions regarding the handling of your data, please
contact the Data Protection Officer employed by MAC Clinical Research:
Dr Steve Higham (The Data Protection Officer)
MAC Clinical Research
Kaman Court,
1 Faraday Way,
Blackpool,
Lancashire,
FY2 0JH, UK

Page 18 of 24
WILL MY GENERAL PRACTITIONER (GP) BE INFORMED?

Your GP will be informed of your participation in this study and we will request
information relating to your medical records from them. If appropriate, your GP may
be consulted about your treatment during the study.
CAN I TAKE PART IN MORE THAN ONE STUDY?
You are not eligible to take part in this study if you are currently enrolled
in another study involving taking medication, or have been enrolled in a different study
within 3 months before the study drug administration. You must not take part in too
many studies because it’s not good for you. So, we and other units like ours in the UK
keep a database (The Over-Volunteering Prevention System) of healthy participants
and some patients and when they take part in studies. We’ll enter your details into the
database, namely:
• your National Insurance number (if you’re a UK citizen); or
• your passport number and country of origin (if you’re not a UK citizen); and
• the date of your last dose of study medicine.
If you withdraw from the study before you receive any study medicine, the database
will show that you never received a dose. Only staff at MAC and other medicines
research units can use the database. We may call other units, or they may call us, to
check your details. We’ll keep your details for at least 2 years. If we need to contact
you, we might be able to trace you through the information in the database.
WHAT ABOUT INSURANCE, TAX AND BENEFITS?
If you have private medical insurance, you should let your insurers know you’re going
to take part in a research project. They’ll tell you if it will affect your insurance.
Depending on your circumstances, you might have to pay income tax on your study
payment. You should declare your income from studies to the Inland Revenue every
year – we won’t do that for you. Occasionally, the Inland Revenue ask us to give them
information about volunteer payments.
If you claim benefits you should declare your income from studies to the Department
for Work and Pensions, because it might affect your benefit payments.
BUSINESS CONFIDENTIALITY
The information and any materials or items that you are given during the Study - such
as information identifying the research unit, the Sponsor, any Study drug(s), and/or
the type of study being performed - should be considered confidential business
information of MAC and the Sponsor. You are of course free to discuss such
information under confidence with your doctor or with your friends and family while
considering whether to participate in this Study or at any time when discussing your
present or future healthcare. However, distributing confidential business information
as described above to the media or posting it on the internet is strictly prohibited and
by signature of this document you agree to this prohibition.

Page 19 of 24
WHAT WILL HAPPEN TO THE RESULTS OF THE RESEARCH STUDY?

The results of this study will be used to develop the study drug and may be used to
inform future scientific research into ED, and yet undefined issues. The results may
be published in the scientific press, however you will not be identified by these results
or within any published scientific literature.
A description of this clinical trial will be available on
https://www.clinicaltrialsregister.eu. This website will not include any information that
may identify you. You can search this website anytime.
WHO WILL COVER THE COSTS FOR MY PARTICIPATION IN THE STUDY?
WILL I BE COMPENSATED?
You will receive a sum of £920 if you complete the trial (Screening and Visits 2 and 3)
to compensate you for your time and participation in the study. If you are not found to
be eligible for the study at screening visit, you will receive £30. Travel expenses will
be paid in addition to this (up to a maximum of £95) for each visit with documentation.
If you are asked to act as a reserve and are not used then you will be paid a sum of
£120.
The following payment rules will apply:
• We won't pay you if you fail a test for recreational drugs or alcohol.
• If you do not follow rules or instructions given to you during the study, then you
may be withdrawn from the study and you will not be paid.
• The payment is to cover your time, trouble and expenses. If we stop the study,
if you don’t finish it for any other reason, or if we cancel one or more study visits,
the payment may be reduced.
• If you choose to withdraw from the trial, you will be paid for the visits you have
attended and the commitment you have given to the trial, up to the point you
withdrew.
• If you have to come back for an extra unscheduled visit, we’ll pay you £25 plus
travel expenses providing you have documentary proof of these.
• If we give you a place on the study but the tests before dosing show you are
not suitable, we’ll pay you £30.
• Even if the screening results show that you are suitable to take part, we can’t
guarantee you a place on the study. We’ll pay you £30 if you pass all the
screening tests but we can’t offer you a place.
• Payments will be made around 30 working days after your very last visit,
providing your results show you don’t need any extra tests.
WHO HAS REVIEWED AND APPROVED THIS STUDY?
International guidelines exist to ensure that clinical studies are performed safely and
ethically. These are called “Good Clinical Practice” and the “Declaration of Helsinki”.
All studies performed at MAC Clinical Research conform to these guidelines. All
research is looked at by an independent group of people, called a Research Ethics

Page 20 of 24
Committee, to protect your interests. This study has been reviewed and given
favourable opinion by a recognised UK Research Ethics Committee.
FURTHER INFORMATION AND CONTACT DETAILS
Thank you for reading this information sheet. Remember, you do not have to take part
in this research if you do not want to and you can stop taking part at any time.
If there is anything you do not understand or if you have other questions, please ask
your study doctor or nurse at the next available opportunity.
Contact details:
Study Doctor:
Name: Dr. Peter Dewland
Address: MAC Clinical Research,
Neuroscience Centre of Excellence,
Citylabs
Nelson Street
Manchester
M13 9NQ
United Kingdom
Telephone number: 0161 275 9966
Please call the above number within office hours (08:30 to 16:30) to speak to a study
doctor, or the same number outside office hours in an emergency to be redirected to
the on-call doctor.
If you have any further questions about your rights as a participant in the study, or
wish to make a formal complaint, you can contact the following independent contact:
Roger Cope, Head of Quality Assurance: 0161 275 9966
All spoken and written information and discussions about this study will be in a
language that you understand.
Do not sign the consent form unless you have had the chance to ask any questions
that you may have and have received satisfactory answers. If you agree to take part
in this study, you will receive a signed and dated copy of this information sheet and
consent form for your records. Thank you for taking the time to read this information.

Page 21 of 24
INFORMED CONSENT FORM
CONFIDENTIAL
A Phase I, Randomised, Double-Blind, Placebo-Controlled, Ascending

Single Oral Dose, Safety, Tolerability, Pharmacokinetic and
Pharmacodynamic Study of IPED2015 in Healthy Male Subjects and
Study Title: Healthy Elderly Male Subjects (Part A and Part B).
A Phase II, Randomised, Placebo-Controlled, Double-Blind, Crossover
Study, Investigating the Effects of a Single Dose of IPED2015 on Erectile
Function in Males with Erectile Dysfunction (Part C).
Protocol
IPED2015CS01
Number:
Principal
Dr. Peter Dewland
Investigator:
Subject Number:
Subject Initials
I agree that I have been fully informed about all aspect of the trial
including information relating to confidentiality of my personal
information and have been given ample time and opportunity to
enquire about details of the trial and decide whether or not to
participate.
I have read and understand the statements in the Participant

Information Sheet Version 4, dated 18 December 2018 for the
above study. All my questions about the study and my participation
in it have been answered to my satisfaction. I am not currently
participating in another study and have not participated in a study
within 3 months.
I freely and voluntarily consent to participate in the study and I am

free to withdraw at any time without giving any reason, without my
legal rights being affected and I understand that the doctors or
Sponsor may stop the study or my participation in the study at any
time without my consent.
I understand that if I withdraw my consent from the study, that the

Sponsor and Study Doctor may continue to use and distribute any
data gathered during the study for purposes outlined in the
participant information sheet.

Page 22 of 24
I authorise the release of my medical records, for research or

regulatory purposes to the sponsors, Initiator Pharma, the
companies working on behalf of Initiator Pharma, regulatory
authorities, Institution review boards, and study doctors, where it
is relevant to my taking part in this research. I give permission to
these individuals to have access to my records.
I agree to my GP being informed of my participation in the study.
I understand that I will receive a signed copy of this consent and

authorisation form. I also understand that the original signed
consent form will be filed with the study doctor.
I understand the information given related to HIV, hepatitis B and

hepatitis C at screening visit and agree to proceed with the tests
as stated in the participant information sheet.
I understand that I am being asked to attend clinic visits at

prescheduled dates and times, and I will let the study site know if I
am unable to do so.
I have read and consent to my data being processed as explained

in the section ‘What will happen to my data during the study?’
in the participant information sheet.
I agree that my anonymised study data may be used as described

in this consent including transfer to countries outside of the EU,
and my personal coded data may be archived for period in excess
of 15 years, consistent with regulatory requirements.
I will let the study doctor know if I have any changes in medication,
am injured, develop any illness, my partner becomes pregnant, or
if I plan to have an elective surgery or medical treatment procedure
during the study.
I agree to my study samples being stored and analysed for use on

this study only as described in the participant information sheet
and if additional analysis is required, my samples will only be used
if I consent to this.
I understand that when volunteering to take part in this Study I

should not give up/turn down any offer of employment nor make
any financial commitment on the expectation of receiving a Study
payment as I am not guaranteed a place on the Study, and that
occasionally studies are postponed or cancelled.

Page 23 of 24
I understand that a decision about whether I am considered eligible

for check-in will be made after a doctor has reviewed all the results
from the screening visit.
I agree not to distribute this document or the confidential business

information described within it (including the research unit details,
the Sponsor, any study drug(s), and/or the type of study being
performed) to the media or to post this information on the internet.
I agree to take part in the above mentioned study being conducted

by MAC Clinical Research.
Written ICF:
PARTICIPANT:
Printed Name:
......................................................................................................
Signature:
......................................................................................................
Time: ...... : ...... Date: ....../....../......
PERSON OBTAINING INFORMED CONSENT:
Printed Name:
......................................................................................................
Signature:
......................................................................................................
Time: ...... : ...... Date: ....../....../......

Page 24 of 24

IPED2015CS01 MAC049 PIS&ICF 4.0 Part A and B (18dec2018) - Final Version

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MAC CLINICAL RESEARCH

Neuroscience Centre Of Excellence, MAC Clinical Research, Citylabs,

Participant Information Sheet

Study Title: A Phase I, Randomised, Double-Blind, Placebo-Controlled,

Final V4.0 Part A and B (18 December 2018)

Final V4.0 Part A and B (18 December 2018)

WHAT IS CLINICAL RESEARCH?

Final V4.0 Part A and B (18 December 2018)

Final V4.0 Part A and B (18 December 2018)

DO I HAVE TO TAKE PART?

Final V4.0 Part A and B (18 December 2018)

Final V4.0 Part A and B (18 December 2018)

Final V4.0 Part A and B (18 December 2018)

Visit 2 Inpatient Visit (Day -1 to Day 3) Part A and B

Final V4.0 Part A and B (18 December 2018)

Visit 3 Follow-up Visit (5 to 7 Days After Visit 2) Part A and B

Reason for Sample Type of What Will Happen to the

Final V4.0 Part A and B (18 December 2018)

Final V4.0 Part A and B (18 December 2018)

Previous Medical History

Final V4.0 Part A and B (18 December 2018)

Final V4.0 Part A and B (18 December 2018)

WHAT ARE THE POSSIBLE DISADVANTAGES AND RISKS OF TAKING PART?

Final V4.0 Part A and B (18 December 2018)

Final V4.0 Part A and B (18 December 2018)

WHAT IF NEW INFORMATION BECOMES AVAILABLE?

WHAT IF THERE IS A PROBLEM?

Final V4.0 Part A and B (18 December 2018)

Economic Area (EEA) where this regulation applies, by a Sponsor or Vendor

Final V4.0 Part A and B (18 December 2018)

WILL MY GENERAL PRACTITIONER (GP) BE INFORMED?

Final V4.0 Part A and B (18 December 2018)

WHAT WILL HAPPEN TO THE RESULTS OF THE RESEARCH STUDY?

Final V4.0 Part A and B (18 December 2018)

Final V4.0 Part A and B (18 December 2018)

INFORMED CONSENT FORM

A Phase I, Randomised, Double-Blind, Placebo-Controlled, Ascending

I have read and understand the statements in the Participant

I freely and voluntarily consent to participate in the study and I am

I understand that if I withdraw my consent from the study, that the

Final V4.0 Part A and B (18 December 2018)

I authorise the release of my medical records, for research or

I agree to my GP being informed of my participation in the study.

I understand that I will receive a signed copy of this consent and

I understand the information given related to HIV, hepatitis B and

I understand that I am being asked to attend clinic visits at

I have read and consent to my data being processed as explained

I agree that my anonymised study data may be used as described

I agree to my study samples being stored and analysed for use on

I understand that when volunteering to take part in this Study I

Final V4.0 Part A and B (18 December 2018)

I understand that a decision about whether I am considered eligible

I agree not to distribute this document or the confidential business

I agree to take part in the above mentioned study being conducted

Time: ...... : ...... Date: ....../....../......

PERSON OBTAINING INFORMED CONSENT:

Time: ...... : ...... Date: ....../....../......

Final V4.0 Part A and B (18 December 2018)

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