Trials / Completed
CompletedNCT03586570
A Study to Evaluate How Aprocitentan is Safe and How it is Absorbed and Broken Down in the Body of Japanese and Caucasian Subjects
A Single-center, Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, and Pharmacokinetics After Multiple-dose Administration of 25 mg Aprocitentan in Healthy Japanese and Caucasian Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Idorsia Pharmaceuticals Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study is to evaluate the tolerability, safety, and pharmacokinetics after multiple-dose administration of aprocitentan (25 mg) in healthy Japanese and Caucasian subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aprocitentan 25mg | Oral tablets in strength of 25 mg |
| DRUG | Placebo | Oral tablets matching aprocitentan tablets |
Timeline
- Start date
- 2018-07-17
- Primary completion
- 2018-09-10
- Completion
- 2018-09-10
- First posted
- 2018-07-13
- Last updated
- 2022-11-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03586570. Inclusion in this directory is not an endorsement.