Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Macitentan
Macitentan/ tadalafil · 2 trials · 1 indication
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....
Macitentan is an investigational small molecule being studied for systemic sclerosis, pulmonary arterial hypertension (PAH, WHO Group 1 PH), congenital heart disease, and heart failure with preserved ejection fraction. It is also used in clinical trials involving healthy subjects. The drug is in Phase 2 development for these indications.
Macitentan is a small molecule being developed for cardiovascular conditions. It is being studied in patients with pulmonary arterial hypertension and heart failure with preserved ejection fraction. The drug's specific molecular target is not disclosed in the available information.
Macitentan is developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 2 clinical development for cardiovascular indications.
Macitentan is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for systemic sclerosis, pulmonary arterial hypertension, congenital heart disease, and heart failure with preserved ejection fraction.
Macitentan has been studied in 10 clinical trials with a total enrollment of 3,395 participants. One trial is active, and nine are completed. Notable trials include NCT04273945, a Phase 3 study of a 75 mg dose in pulmonary arterial hypertension, and NCT03153111, a Phase 2 study in heart failure with preserved ejection fraction.
Yes, Macitentan is also known as Macitentan 10 mg. This alternative name refers to the 10 mg dosage form of the drug. The drug is being developed by Johnson & Johnson under the ticker JNJ.