Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult Subjects

Clementia Pharmaceuticals Inc.48 enrolled

Overview

Study to evaluate the effect of food and the effect of swallowing capsule whole versus sprinkling on apple sauce on the pharmacokinetics (PK)/bioavailability of palovarotene, and evaluate the effect of palovarotene on the PK of the CYP3A4 substrate midazolam.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fibrodysplasia Ossificans Progressiva

Interventions

PalovaroteneDRUG

oral capsules

midazolamDRUG

oral syrup

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key Inclusion Criteria: * Generally healthy male or female aged 18 to 55 years, inclusive; body mass index (BMI) of 18 to 30 kg/m2 and a body weight of \>50 kg; resting pulse of \>45 bpm and \<100 bpm; systolic and diastolic blood pressure of \<140/90 mmHg Key Exclusion Criteria: * a history or current evidence of a clinically significant or uncontrolled disease, disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs * exposure to synthetic oral retinoids or creams containing retinoids in the past 30 days prior to the signature of the informed consent. * history or presence of silent infections, including positive tests for human immunodeficiency virus type 1 (HIV-1), human immunodeficiency virus type 2 (HIV-2), hepatitis B virus (HBV), or hepatitis C virus (HCV) * history of allergy or hypersensitivity to retinoids, gelatin, or lactose * For the DDI component only, the subject had a history of allergy or hypersensitivity to benzodiazepines, midazolam, cherries, or midazolam formulation excipients

Locations (1)

Cambridge Ipsen US

Cambridge, Massachusetts, United States

Outcomes