Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Selexipag matrix · 1 trial · 1 indication
The Cmax is the maximum observed analyte concentration.
AUC (0-last) defined as the area under the analyte concentration-time curve from time zero to time of the last measurable (non-BQL) analyte concentration, calculated by linear-linear trapezoidal summation.
C24 defined as plasma analyte concentration at 24 hours postdose.
AUC (0-infinity) is defined the area under the analyte concentration-time curve from time zero to infinity time, calculated as the sum of AUC (0-last) and C(last)/lambda(z); wherein AUC (0-last) is area under the plasma concentration-time curve from time zero to last measurable concentration, C(last) is the last observed measurable concentration, and lambda(z) is apparent terminal elimination rate constant.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Selexipag Matrix Tablets | EXPERIMENTAL | Participants will receive oral doses of selexipag matrix tablets based on release profiles (IR=immediate release, F=fast release, M=medium release and S=slow release) in treatment sequence 1 (IR+F+M+S), treatment sequence 2 (F+S+IR+M), treatment sequence 3 (M+ IR+ S+F) and treatment sequence 4 (S+M+F+IR) in periods 1, 2, 3, and 4, respectively under fasted condition. A washout period of at least 7 days will be maintained between each treatment period. |
| Cohort 2: Selexipag Encapsulated Pellets | EXPERIMENTAL | Participants will receive oral doses of selexipag encapsulated) pellets based on release profiles (IR=immediate release, F=fast release, M=medium release and S=slow release) in treatment sequence 1 (IR+F+M+S), treatment sequence 2 (F+S+IR+M), treatment sequence 3 (M+ IR+ S+F) and treatment sequence 4 (S+M+F+IR) in periods 1, 2, 3, and 4, respectively under fasted condition. A washout period of at least 7 days will be maintained between each treatment period. |
| Name | Type | Description |
|---|---|---|
| Selexipag matrix tablet | DRUG | Participants will receive single oral dose of Selexipag tablet(with fast, medium, and slow release profile) under fasted condition. |
| Selexipag encapsulated pellets | DRUG | Participants will receive single oral dose of Selexipag pellets (with fast, medium, and slow release profile) under fasted condition. |
| Selexipag Immediate-release (IR) tablet | DRUG | Participants will receive Selexipag immediate-release tablet orally under fasted condition. |
Inclusion Criteria: * Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening * Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, hematology, or urinal...
Selexipag matrix is an investigational small molecule being developed by Johnson & Johnson (JNJ). It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers, specifically in a completed trial involving healthy male participants.
Selexipag matrix is being studied for use in healthy individuals, as part of early-phase clinical research. The completed Phase 1 trial enrolled healthy male participants to evaluate the drug. Its intended therapeutic use in patients has not been established.
Selexipag matrix is being developed by Johnson & Johnson, which trades under the ticker JNJ on the stock exchange. The company is conducting clinical research on this investigational small molecule drug.
Selexipag matrix is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research.
Selexipag matrix has one completed Phase 1 clinical trial, identified as NCT04266756. This study, titled 'A Study of Selexipag in Healthy Male Participant,' enrolled 24 healthy male participants in Belgium. The trial was controlled and randomized, with participants aged 18 years and older.
Selexipag matrix is a formulation of selexipag, a drug used for pulmonary arterial hypertension. The 'matrix' designation indicates a specific formulation being studied in early-phase trials. This investigational version is being developed by Johnson & Johnson for potential therapeutic use.