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Also known as Selexipag matrix tablet
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 developed by Johnson & Johnson (ticker JNJ). It is a matrix tablet formulation studied in a Phase 1 clinical trial in healthy male participants. The program is in early clinical development, and no approved indication has been disclosed for this matrix formulation.
Selexipag matrix targets PTGIR, the prostacyclin receptor, and acts as an agonist at that receptor. Agonist activity at PTGIR is the mechanism described for this asset. The matrix tablet is a small molecule formulation being evaluated in Phase 1 testing by Johnson & Johnson.
Selexipag matrix is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is the sponsor behind the Phase 1 program for this matrix tablet formulation of selexipag. Development remains at the early clinical stage.
Selexipag matrix is in Phase 1 clinical development. It is investigational and has not been approved. One Phase 1 trial has been completed, with no active trials currently listed. The completed study enrolled 24 participants and was conducted in Belgium.
Selexipag matrix has been studied in one completed Phase 1 trial, NCT04266756, titled A Study of Selexipag in Healthy Male Participant. That randomized, controlled trial enrolled 24 healthy male volunteers aged 18 years and older in Belgium. No active trials are currently listed for this asset.
Yes, Selexipag matrix and Selexipag matrix tablet refer to the same asset. The matrix tablet is the alternative name used for this formulation of selexipag. Both names point to the same Phase 1 small molecule program targeting PTGIR that is being developed by Johnson & Johnson.