Trials / Completed
CompletedNCT03389321
Clinical Study to Investigate Effect of Macitentan on Riociguat Pharmacokinetics
A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of Macitentan at Steady State on the Pharmacokinetics of Riociguat in Healthy Male Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Actelion · Industry
- Sex
- Male
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
Both macitentan and riociguat are indicated in the treatment of pulmonary arterial hypertension (PAH) and may be administered concomitantly. The primary objective of this study is to evaluate the effect of macitentan administered for 11 days on the pharmacokinetics (PK) (i.e., amount and time of presence in the blood of riociguat) of a single dose of riociguat in healthy male subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Riociguat (Adempas) | Riociguat film-coated tablets for oral administration at a strength of 1 mg |
| DRUG | Macitentan (Opsumit) | Macitentan film-coated tablets for oral administration at a strength of 10 mg |
Timeline
- Start date
- 2018-01-09
- Primary completion
- 2018-02-06
- Completion
- 2018-02-06
- First posted
- 2018-01-03
- Last updated
- 2018-02-08
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03389321. Inclusion in this directory is not an endorsement.