Trials / Completed
CompletedNCT02050802
Study to Assess the Effect of Macitentan on the Electrocardiogram (ECG) in Healthy Male and Female Subjects
A Double-blind, Randomized, Placebo-controlled, Four-way Crossover Phase 1 Study Including an Open-label Positive Control (Moxifloxacin) to Assess the Effect of Repeated Daily Doses of 10 mg and 30 mg Macitentan on the QT/QTc Interval of the ECG in Healthy Male and Female Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Actelion · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The study is intended to demonstrate that macitentan does not have an effect on cardiac repolarization exceeding the threshold of regulatory concern after repeated administration of daily oral doses of 10 and 30 mg to healthy male and female subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Moxifloxacin 400 mg | |
| DRUG | Macitentan 10 mg | |
| DRUG | Macitentan 30 mg | |
| OTHER | Placebo |
Timeline
- Start date
- 2011-08-01
- Primary completion
- 2011-11-01
- Completion
- 2011-11-01
- First posted
- 2014-01-31
- Last updated
- 2025-02-03
Source: ClinicalTrials.gov record NCT02050802. Inclusion in this directory is not an endorsement.