Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03389321 | Clinical Study to Investigate Effect of Macitentan on Riociguat Pharmacokinetics | PHASE1 | COMPLETED | 20 | — | — | Jan 9, 2018 | Feb 6, 2018 | Feb 8, 2018 | 1 | Germany |
AUC(0-inf) of riociguat will be assessed following administration of riociguat alone or concomitantly with macitentan.
The maximum observed plasma concentration of riociguat will be assessed following administration of riociguat alone or concomitantly with macitentan.
| Arm | Type | Description |
|---|---|---|
| Treatment A-B | EXPERIMENTAL | All subjects will receive treatment A followed by treatment B. Treatment A consists of a single oral dose (1 mg) of riociguat (Adempas) on Day 1. Treatment B consists of a loading oral dose of 30 mg macitentan (Opsumit) (3 tablets of 10 mg) on Day 5, then 10 mg of macitentan once daily from Day 6 to Day 15, with a concomitant administration of riociguat (1 mg) on Day 10. |
| Name | Type | Description |
|---|---|---|
| Riociguat (Adempas) | DRUG | Riociguat film-coated tablets for oral administration at a strength of 1 mg |
| Macitentan (Opsumit) | DRUG | Macitentan film-coated tablets for oral administration at a strength of 10 mg |
Key Inclusion Criteria: * Male subjects aged between 18 and 45 years (inclusive) at screening who signed informed consent prior to any study-mandated procedure; * Healthy on the basis of physical examination, cardiac evaluations (12-lead ECG) and laboratory tests performed at screening; * Body mass...