NCT02882425

Absolute Bioavailability of a Single Oral Dose of Selexipag in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Actelion · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

A pilot phase was conducted in 3 male subjects before the main phase for assessment of absolute bio-availability conducted in 16 other male subjects. The pilot phase aimed to determine the intravenous dose to be used in the main phase based on safety data and pharmacokinetics data.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Selexipag for intravenous use	Selexipag was reconstituted in sterile 0.9% w/v NaCl before infusion via an infusion pump at a rate of 2.5 µg/min.
DRUG	Selexipag for oral use	Tablet containing 200 µg of selexipag

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2016-08-29
• Last updated: 2025-02-03