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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04266756 | A Study of Selexipag in Healthy Male Participant | PHASE1 | COMPLETED | 24 | — | — | Jan 23, 2020 | Aug 14, 2020 | Mar 30, 2025 | 1 | Belgium |
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...