A Phase 1, open-label, single-dose, single-center, mass balance study of IPN60130 following a single 60-mg oral dose of IPN60130 containing 9 µCi of [14C]-IPN60130 in healthy male participants

Completed

• Conditions: fibrodysplasia ossificans progressiva (FOP); 10028396

• Registration Number: NL-OMON50811
• Lead Sponsor: Ipsen Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2022-09-02
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• To determine the PK of 14C radioactivity in whole blood and plasma after a<br /><br>single oral dose of [14C] IPN60130.<br /><br>• To determine the mass balance, metabolism and elimination pathway(s) of [14C]<br /><br>IPN60130.<br /><br>• To determine the PK of IPN60130 in plasma and urine.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To identify and quantify metabolites of IPN60130 in plasma, urine and faecal<br /><br>samples.<br /><br>• To evaluate the safety and tolerability of IPN60130.</p><br>