Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Selexipag for intravenous use
Selexipag for use · 1 trial · 1 indication
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 ...
Selexipag for intravenous use is an investigational small molecule developed by Johnson & Johnson (ticker JNJ). It is a formulation of selexipag studied for intravenous administration. The program is in Phase 1 clinical development, and the specific therapeutic indication has not been disclosed.
Selexipag for intravenous use targets PTGIR, the prostacyclin receptor. It acts as an agonist at this receptor, meaning it activates the receptor. PTGIR agonism is the mechanism associated with this small molecule in its clinical development program.
Selexipag for intravenous use is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is the sponsor behind the clinical development program for this intravenous formulation of selexipag.
Selexipag for intravenous use is in Phase 1 clinical development. It is an investigational agent and is not approved for any use based on this program. One Phase 1 trial has been completed, and no trials are currently active.
Selexipag for intravenous use has been studied in one completed Phase 1 trial, NCT02882425, titled Absolute Bioavailability of a Single Oral Dose of Selexipag in Healthy Subjects. That randomized, controlled trial enrolled 19 healthy male volunteers aged 18 years and older.
Selexipag for intravenous use is an alternative name for selexipag, referring to the intravenous formulation of the same small molecule. Searches for either name refer to the same investigational agent developed by Johnson & Johnson.