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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03359291 | Clinical Study to Investigate the Effect of Macitentan on the Concentrations of Rosuvastatin in the Blood of Healthy Male Subjects | PHASE1 | COMPLETED | 20 | — | — | Nov 3, 2017 | Dec 4, 2017 | Jun 22, 2025 | 1 | Germany |
| NCT03215966 | A Study to Compare the Macitentan-tadalafil Fixed Dose Combination Tablet Relative to the Concomitant Administration of the Reference Tablets of Macitentan and Tadalafil in Healthy Subjects | PHASE1 | COMPLETED | 38 | — | — | Aug 7, 2017 | Sep 24, 2017 | Jun 22, 2025 | 1 | Germany |
AUC(0-inf) is the area under the plasma concentration-time curves of rosuvastatin, calculated from time zero to the extrapolated infinite time
Cmax is the maximum observed plasma concentration and is directly derived from the individual plasma concentration time curves of rosuvastatin
The measured individual plasma concentrations of macitentan and tadalafil are used to directly obtain Cmax
AUC(0-t) is the area calculated from the concentration-time profile of macitentan and tadalafil, from time 0 to to time t of the last measured concentration above the limit of quantification
AUC(0-inf) is the area calculated from the concentration-time profile of macitentan and tadalafil, from time 0 to extrapolated infinite time
| Arm | Type | Description |
|---|---|---|
| Sequence AB | EXPERIMENTAL | Subjects participate in two study periods: During the first period (treatment A), they receive a single oral dose of rosuvastatin on Day 1. During the second period (treatment B), they receive a single oral loading dose of macitentan on Day 5 and oral doses of macitentan from Day 6 to Day 16 (i.e., 11 doses). Subjects receive a single oral dose of 10 mg rosuvastatin concomitantly with macitentan in the morning of Day 10. |
| Sequence A/B | EXPERIMENTAL | Subjects receive one tablet of macitentan / tadalafil FDC (fixed dose combination) during Period 1, then after a washout period of at least 7 days they receive one tablet of macitentan (Opsumit®) and two tablets of tadalafil (Adcirca®) during Period 2 |
| Sequence B/A | EXPERIMENTAL | Subjects receive one tablet of macitentan (Opsumit®) and two tablets of tadalafil (Adcirca®) during Period 1, then after a washout period of at least 7 days, they receive one tablet of macitentan / tadalafil FDC (fixed dose combination) during Period 2 |
| Name | Type | Description |
|---|---|---|
| Rosuvastatin | DRUG | Single oral dose of 10 mg rosuvastatin (film-coated tablet) on Day 1 and Day 10 |
| Macitentan | DRUG | Single oral dose of 30 mg macitentan (film-coated tablet) on Day 5 and 10 mg macitentan administered orally from Day 6 to Day 16 |
| Macitentan / tadalafil FDC | COMBINATION_PRODUCT | Tablets for oral administration containing 10 mg of macitentan and 40 mg of tadalafil |
| Macitentan (Opsumit®) | DRUG | Film-coated tablets for oral administration formulated at a strength of 10 mg |
| Tadalafil (Adcirca®) | DRUG | Film-coated tablets for oral administration formulated at a strength of 20 mg |
Principal Inclusion Criteria: * Signed informed consent in the local language prior to any study-mandated procedure. * Healthy male subjects aged between 18 and 55 years (inclusive) at screening. * No clinically significant findings on the physical examination at screening. * Body mass index of 18....