In this study we will investigate how quickly and to what extent the new compound IPN60130 is absorbed, transported, and eliminated from the body (this is called pharmacokinetics). IPN60130 is radioactively labelled with carbon-14 (14C). In this way…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue disorders congenital
- Musculoskeletal and connective tissue disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• To determine the PK of 14C radioactivity in whole blood and plasma after a
single oral dose of [14C] IPN60130.
• To determine the mass balance, metabolism and elimination pathway(s) of [14C]
IPN60130.
• To determine the PK of IPN60130 in plasma and urine.
Secondary outcome
• To identify and quantify metabolites of IPN60130 in plasma, urine and faecal
samples.
• To evaluate the safety and tolerability of IPN60130.
Background summary
This study involves the use of an investigational drug called IPN60130. An
investigational drug is a drug that has not been approved by Regulatory
Agencies, but may be used in research studies like this one.
In this study we will investigate how quickly and to what extent IPN60130 is
absorbed, distributed, metabolized (broken down) and excreted from the body,
and what is the main route of excretion from the body (urine or feces); this is
called pharmacokinetics. IPN60130 is radioactively labelled with carbon-14
(14C). In this way IPN60130 and its metabolites can be traced in blood, urine,
and feces.
We also investigate how safe IPN60130 is and how well it is tolerated when it
is used by healthy participants.
IPN60130 is in development and is not registered as a drug but has been given
to healthy volunteers as a single dose first and then as repeated doses before.
In addition, it has been extensively tested in the laboratory and on laboratory
animals.
Study objective
In this study we will investigate how quickly and to what extent the new
compound IPN60130 is absorbed, transported, and eliminated from the body (this
is called pharmacokinetics). IPN60130 is radioactively labelled with carbon-14
(14C). In this way IPN60130 can be traced in blood, urine, and feces.
We also investigate how safe IPN60130 is and how well it is tolerated when it
is used by healthy participants.
IPN60130 has been used by humans before. In addition, it has been extensively
tested in the laboratory and on animals.
Study design
The study will take a maximum of 9 weeks from the screening until the follow-up
visit.
For the study it is necessary that subjects stay in the research center for 1
period of 16 days (15 nights). The amount of radioactivity in urine and feces
will be measured daily from Day 1 onwards. If, on Day 15, the radioactivity
levels in urine and feces are not below the pre-defined levels, they will
return to the research center for 24-hour collection of urine and feces from
Day 22 to Day 23 and Day 29 to Day 30. For these collection intervals, they are
expected in the research center in the afternoon of Day 22 and Day 29, and they
can leave after the 24-hour collection interval (Day 23 and Day 30). They will
need to collect feces at home in the 24 hours before these visits.
Day 1 is the day when subjects receive the study compound. They will need to
collect feces at home in the 48 hours before arrival at the research center.
They will leave the research center on Day 15 of the study.
Below is an overview of the days subjects stay at the research center, or when
they visit the research center.
Screening -> Day -28 up to Day 2
Stay - Arrival -> Day -1
Stay - In-house stay -> Day -1 up to Day 15
Stay - Departure -> Day 15
Conditional Visits - 24-hour visit -> Day 22 to Day 23
Conditional Visits - 24-hour visit -> Day 29 to Day 30
Follow-up -> 7 days after discharge or the last 24-hour visit
Intervention
Subjects will be given IPN60130 as an oral solution of 30 milliliters (mL)
after an overnight fast (no eating for at least 10 hours). After administration
of the study compound, the vial will be rinsed twice times with 30 mL of water,
which they will also be required to drink. Thereafter they are also required to
drink an additional amount of 120 mL of water. After administration of the
study compound on Day 1, they will be required to fast for an additional 4
hours. Then they will be served lunch. Drinking of water is allowed except for
from 1 hour before administration of the study compound until 1 hour after
administration of the study compound.
The planned treatment of the study is as follows:
Day | Treatment | Formulation | How often
1 | IPN60130 in 30 mL, containing 60 mg IPN60130 mixed with 14C radiolabeled
IPN60130 | Oral solution | Once
Study burden and risks
Blood draw
Drawing blood may be painful or cause some bruising. The use of the indwelling
canula can sometimes lead to inflammation, swelling, hardening of the vein,
blood clotting, and bleeding in the environment (bruising) of the puncture
site. In some individuals, a blood draw can sometimes cause pallor, nausea,
seating, low heart rate, or drop in blood pressure with dizziness or fainting.
Blood samples will be collected at least 28 times during participation in this
research study. In total, we will take about 360 mL of blood. This amount does
not cause any problems in adults. To compare: a blood donation involves 500 mL
of blood being taken each time. If the investigator thinks it is necessary for
the safety of a participant, extra samples might be taken for possible
additional testing. If this happens, the total amount of blood drawn will be
more than the amount indicated above.
Heart tracing
To make a heart tracing, electrodes will be placed at specific locations on
arms, chest and legs. Prolonged use of these electrodes can cause skin
irritation (rash and itching).
Coronavirus test
Samples for the coronavirus test will be taken from the back of the nose and
throat using swabs. Taking the samples only takes a few seconds, but can cause
discomfort and can give an unpleasant feeling. Taking a sample from the back of
the throat may cause subject to gag. When the sample is taken from the back of
the nose, they may experience a stinging sensation and the eyes may become
watery.
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Listed location countries
Age
Inclusion criteria
Age
1. Participant must be 18 to 55 years of age inclusive, at the time of signing
informed consent.
Type of Participant and Disease Characteristics
2. The participant must be generally healthy, in the opinion of the
Investigator, as determined by medical history, physical examination, 12-lead
ECG, vital signs and clinical laboratory results obtained within 28 days prior
to enrolment in the study.
3. The participant must have a resting (at least 5 minutes) supine pulse of >40
but <100 beats per minute and systolic and diastolic blood pressure (BP)
<140/90 mmHg at screening. (Note: BP may be retested twice at intervals of at
least 5 minutes. The BP is considered sustained if either the diastolic or
systolic value exceeds the limits in all 3 assessments).
Weight
4. The participant must have a body mass index (BMI) of 18 to 30 kg/m² (both
inclusive) (calculated as weight [kg]/height [m²]) and a body weight of 50 kg
or more at screening.
Sex
5. Male
Male participants:
Agree to the following during the study intervention period and for at least 90
days after the dose of study intervention:
• Refrain from donating sperm
PLUS, either
• Be abstinent from heterosexual intercourse as their preferred and usual
lifestyle (abstinent on a long term and persistent basis) and agree to remain
abstinent
OR
• Must agree to use contraception as detailed below
Agree to use a male condom with female partner use of an additional highly
effective contraceptive method with a failure rate of <1% per year as described
in Appendix 10.4 Contraceptive and Barrier Guidance when having sexual
intercourse with a woman of childbearing potential who is not currently
pregnant.
Informed Consent
6. Capable of giving signed informed consent as described in Appendix 10.1,
which includes compliance with the requirements and restrictions listed in the
informed consent form (ICF) and in the protocol.
Exclusion criteria
Medical conditions
1. The participant has a history or current evidence of a clinically
significant or uncontrolled (in the opinion of the Investigator) disease,
including but not limited to the following systems: cardiovascular, infectious,
hepatic, renal, haematological, neurological, psychiatric, endocrine,
gastrointestinal, reproductive, pulmonary, or ocular. Significant is defined as
any disease that, in the opinion of the Investigator, would put the safety of
the participant at risk through participation or that could affect the endpoint
analysis if the disease/condition worsened during the study.
2. The participant has any surgical or medical condition known to interfere
with the absorption, distribution, metabolism, or excretion of drugs.
3. The participant was hospitalized for any significant medical disorder within
the past year, in the opinion of the Investigator.
4. The participant has a history of any major surgery within 6 months or
anticipated surgery prior to Day-1.
5. The participant has a history of alcohol abuse, physical dependence to any
opioid, or any history of drug abuse or addiction within 6 months prior to
screening.
6. The participant has a previously identified allergy or hypersensitivity to
components of the study intervention formulation or related compounds or
hypersensitivity to any inactive component of the drug product, unless the
reaction is deemed irrelevant to the study by the Investigator.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-001681-38-NL |
| CCMO | NL78032.056.21 |