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NCT04829773 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Fibrodysplasia Ossificans Progressiva, sponsored by Clementia Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT04829773: Completed Phase 1 study of Fibrodysplasia Ossificans Progressiva, sponsored by Clementia Pharmaceuticals.
NCT04829773 is a Phase 1 study of Fibrodysplasia Ossificans Progressiva that has completed, run by Clementia Pharmaceuticals. The registered enrollment target is 48 participants, below the 92-participant average among 4 other Fibrodysplasia Ossificans Progressiva trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04829773, a Phase 1 study of Fibrodysplasia Ossificans Progressiva, has completed, sponsored by Clementia Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study 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 of palovarotene on the PK of the CYP3A4 substrate midazolam.
Conditions Studied
Interventions
- DRUG midazolam
- DRUG Palovarotene
Study Locations (1)
Massachusetts
- Cambridge Ipsen US - Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-01-03 |
| Est. Completion | 2019-03-29 |
| Phase | Phase 1 |
What the finished NCT04829773 record still lists
NCT04829773 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 92-participant average among 4 other Fibrodysplasia Ossificans Progressiva trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Fibrodysplasia Ossificans Progressiva appearing as the primary indexed condition, and to 2 interventions - of which midazolam is the first listed.
NCT04829773 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04829773 about?
NCT04829773 is a clinical study titled "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". 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.
What is the current status of trial NCT04829773?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2019-01-03. Estimated completion is 2019-03-29.
What conditions does trial NCT04829773 study?
This clinical trial studies the following conditions: Fibrodysplasia Ossificans Progressiva.
What interventions are being tested in trial NCT04829773?
The interventions under investigation include: midazolam (DRUG), Palovarotene (DRUG).
Who is sponsoring clinical trial NCT04829773?
This trial is sponsored by Clementia Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04829773 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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