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
Completed · Phase 1
Conditions studied: Fibrodysplasia Ossificans Progressiva
In brief
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.
Key facts
- Study ID
- NCT04829773
- Run by
- Clementia Pharmaceuticals Inc.
- People needed
- 48
- Starts
- 2019-01-03
- Expected to finish
- 2019-03-29
- Last updated by the study team
- 2021-04-02
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
Where it is running
- Cambridge Ipsen US — Cambridge, Massachusetts, United States
Full record on ClinicalTrials.gov
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