Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Riociguat · 1 trial · 1 indication
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...
Riociguat is a small molecule drug being developed by Johnson & Johnson (JNJ). It is currently in Phase 1 clinical development for use in healthy subjects. The drug is being studied to understand its pharmacokinetics, particularly how it interacts with other medications.
Riociguat is being studied for use in healthy subjects. The current clinical trial is designed to investigate the effect of macitentan on riociguat pharmacokinetics, which means it is being used to understand how the drug is processed in the body when taken with another medication.
Riociguat is being developed by Johnson & Johnson, a pharmaceutical company traded on the stock exchange under the ticker symbol JNJ. The company is conducting clinical research to evaluate the drug's pharmacokinetics in healthy volunteers.
Riociguat is in Phase 1 clinical development. It is an investigational drug, meaning it is not yet approved for any medical use. The current Phase 1 trial has been completed and involved 20 healthy male participants in Germany.
Riociguat has one completed clinical trial registered under NCT03389321. The trial, titled 'Clinical Study to Investigate Effect of Macitentan on Riociguat Pharmacokinetics,' was a Phase 1 study conducted in Germany with 20 healthy male volunteers aged 18 years and older.
Riociguat is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied in healthy subjects to evaluate its pharmacokinetics, but it has not yet received regulatory approval for any indication.