fibrodysplasia ossificans progressiva (FOP)
Conditions
Interventions
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 rin
Sponsors
Ipsen Pharmaceuticals
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
Exclusion criteria
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| • 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
| Measure | Time frame |
|---|---|
| • To identify and quantify metabolites of IPN60130 in plasma, urine and faecal samples. • To evaluate the safety and tolerability of IPN60130. | — |
Countries
Netherlands
Outcome results
None listed