Palovarotene
Sponsors
Clementia Pharmaceuticals Inc., Ipsen
Conditions
Dry Eye DiseaseFibrodysplasia Ossificans ProgressivaFibrodysplasia Ossificans Progressiva (FOP)HealthyHepatic Impairment
Phase 1
Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Palovarotene Ophthalmic Solution in Healthy Adult Subjects
CompletedNCT04762355
Start: 2018-08-30End: 2019-01-03Updated: 2021-02-21
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
CompletedNCT04829773
Start: 2019-01-03End: 2019-03-29Updated: 2021-04-02
A Study of the Blood Levels of Palovarotene in Participants With Abnormal Liver Function Compared to Healthy Adult Participants After Intake of a Single Dose
CompletedNCT06908954
Start: 2025-03-14End: 2026-02-06Updated: 2026-04-30
Phase 2
An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects
CompletedNCT02190747
Start: 2014-07-14End: 2016-05-23Updated: 2021-02-16
In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects
TerminatedNCT02521792
Start: 2015-12-07End: 2016-08-04Updated: 2020-10-19
Phase 3
An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva.
CompletedNCT03312634
Start: 2017-11-30End: 2022-09-07Updated: 2023-11-29
A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.
CompletedNCT05027802
Start: 2022-03-14End: 2024-11-30Updated: 2025-06-22