Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04829773

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

Fibrodysplasia Ossificans Progressiva Clinical Trial

Official title:
An Open-Label 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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

  • Fibrodysplasia Ossificans Progressiva
Clinical Trial Details
NCT number NCT04829773
Study type Interventional
Source Ipsen
Contact
Status Completed
Phase Phase 1
Start date January 3, 2019
Completion date March 29, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT02279095 - An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP) Phase 2
Completed NCT03312634 - An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva. Phase 3
Completed NCT02979769 - An Open-Label Extension Study of Palovarotene to Prevent Heterotopic Ossification in People With Fibrodysplasia Ossificans Progressiva (FOP) in France Phase 2
Recruiting NCT05394116 - A Study to Assess Safety, Tolerability and Efficacy of Garetosmab Versus Placebo Administered Intravenously (IV) in Adult Participants With Fibrodysplasia Ossificans Progressiva (FOP) Phase 3
Completed NCT02066324 - Urine Sample Collection From FOP Patients N/A
Completed NCT02190747 - An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects Phase 2
Completed NCT04665323 - An International Cross-sectional Survey to Evaluate the Burden of Fibrodysplasia Ossificans Progressiva (FOP) on Patients and Their Families.
Completed NCT03188666 - A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva Phase 2
Terminated NCT02521792 - In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects Phase 2
Completed NCT02322255 - A Natural History Study of Fibrodysplasia Ossificans Progressiva (FOP)
Recruiting NCT05039515 - A Study to Assess the Effectiveness and Safety of 2 Dosage Regimens of Oral Fidrisertib (IPN60130) for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP). Phase 2
Recruiting NCT04307953 - Saracatinib Trial TO Prevent FOP Phase 2
Not yet recruiting NCT06089616 - A Study to Document and to Further Describe Long-term Safety and Effectiveness of Palovarotene in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
Completed NCT04818398 - Study of Single-Ascending Doses of DS-6016a in Healthy Japanese Subjects Phase 1