Status:
COMPLETED
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
Lead Sponsor:
Clementia Pharmaceuticals Inc.
Conditions:
Fibrodysplasia Ossificans Progressiva
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 o...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
January 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2019
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04829773
Start Date
January 3 2019
End Date
March 29 2019
Last Update
April 2 2021
Active Locations (1)
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1
Cambridge Ipsen US
Cambridge, Massachusetts, United States, 02142