drugset / Trial / NCT02050802
Study to Assess the Effect of Macitentan on the Electrocardiogram (ECG) in Healthy Male and Female Subjects
RandomizedCrossoverTriple-blindOther
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.
Timeline
- Start
- 2011-08
- Primary completion
- 2011-11
- Completion
- 2011-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Macitentan | Other / unclassified | 10 mg | Oral |
| Subject | Macitentan | Other / unclassified | 30 mg | Oral |
| Subject | Moxifloxacin | Small molecule | 400 mg | — |
Indications
No indication recorded.