Trials / Completed
CompletedNCT04829786
Study to Compare the Pharmacokinetics, Safety, and Tolerability Following Administration of Palovarotene in Healthy Japanese and Non-Asian Subjects
A Double-Blind, Randomized, Cross-Over Single-Dose Study to Compare the Pharmacokinetics, Safety, and Tolerability Following Administration of Palovarotene in Healthy Japanese and Non-Asian Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Clementia Pharmaceuticals Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
this study purpose is to assess safety, tolerability and the pharmacokinetic (PK) profile of palovarotene in healthy Japanese and matched (with respect to sex, age, and weight) non-Asian subjects aged 18 to 55 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | palovarotene low-dose | oral capsules |
| DRUG | palovarotene high-dose | oral capsules |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2015-10-23
- Completion
- 2015-10-23
- First posted
- 2021-04-02
- Last updated
- 2021-04-02
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04829786. Inclusion in this directory is not an endorsement.