Single-center, Open-label, Phase 1 Study Consisting of a Single-dose Pilot Phase and a Randomized, Two-way Crossover, Single-dose Main Phase to Investigate the Absolute Bioavailability of a Single Oral Dose of Selexipag in Healthy Male Subjects

NCT02882425 Phase 1 COMPLETED

The primary purpose of this phase 1 study is to investigate the absolute bio-availability of a single oral dose of selexipag, i.e., to assess the amount of selexipag which reaches the blood when administered as an oral tablet (ACT-293987) compared to an intravenous administration in healthy subjects.

Details

Lead sponsor	Actelion
Phase	Phase 1
Status	COMPLETED
Enrolment	19
Start date	2015-01
Completion	2015-04

Conditions

• Healthy Subjects

Interventions

• Selexipag for intravenous use
• Selexipag for oral use

Primary outcomes

• Absolute bioavailability (F) of selexipag — From pre-dose to 72 hours post-dose
  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
• Area under the plasma concentration-time curve from time 0 to infinity [AUC(0-inf)] of selexipag — From pre-dose to 72 hours post-dose
  AUC(0-inf) was calculated from the concentration-time profile of selexipag after both oral and intravenous administration during the main phase