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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02882425 | Absolute Bioavailability of a Single Oral Dose of Selexipag in Healthy Subjects | PHASE1 | COMPLETED | 19 | — | — | Jan 1, 2015 | Apr 1, 2015 | Feb 3, 2025 | - | — |
F was calculated using the areas under the plasma concentrations curves extrapolated to infinity \[AUC(0-inf)\] after oral (po) and intravenous (iv) doses, obtained during the main phase, and using the following formula: AUC(0-inf)po \* iv dose / AUC(0-inf)iv \* oral dose
AUC(0-inf) was calculated from the concentration-time profile of selexipag after both oral and intravenous administration during the main phase
| Arm | Type | Description |
|---|---|---|
| Intravenous selexipag (Pilot phase) | EXPERIMENTAL | Subjects received a 20-minute intravenous (i.v.) infusion of 50 µg selexipag |
| Sequence A-B (Main phase) | EXPERIMENTAL | Subjects received a 80-minute i.v. infusion of 200 µg selexipag during Period 1, and 2 tablets of oral selexipag (total dose of 400 µg) as a single administration during Period 2. A washout period of 7 to 10 days separated the i.v. infusion from the oral administration. |
| Sequence B-A (Main phase) | EXPERIMENTAL | Subjects received 2 tablets of oral selexipag (total dose of 400 µg) as a single administration during Period 1, and a 80-minute i.v. infusion of 200 µg selexipag during Period 2. A washout period of 7 to 10 days separated the oral administration from the i.v. infusion. |
| Name | Type | Description |
|---|---|---|
| Selexipag for intravenous use | DRUG | Selexipag was reconstituted in sterile 0.9% w/v NaCl before infusion via an infusion pump at a rate of 2.5 µg/min. |
| Selexipag for oral use | DRUG | Tablet containing 200 µg of selexipag |
Inclusion Criteria: * Signed informed consent prior to any study-mandated procedure * Aged from 18 to 45 (inclusive) at screening * Body mass index (BMI) from 18.0 to 28.0 kg/m2 (inclusive) at screening * Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests ...