NCT02745860

Comparison of Two Dose Strengths of Selexipag in Healthy Adults

Single-center, Open-label, Randomized, Two-way Crossover Study in Healthy Adult Male Subjects to Compare the Pharmacokinetics of Selexipag (ACT-293987) Following Single Oral Administration of 4 Film-coated Pediatric Tablets of 50 µg vs One Film-coated Tablet of 200 µg Selexipag

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Actelion · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the tablet developed for children.

Detailed description

Healthy male adults receive a single dose of selexipag (200 µg) but using a different tablet strength (4 film-coated pediatric tablets of 50 µg versus one film-coated tablet of 200 µg selexipag) during each of the two study periods. There is a washout of 7-9 days between the two study treatment administrations.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Selexipag (adult formulation)	One selexipag film-coated tablet of 200 µg
DRUG	Selexipag (pediatric formulation)	Four selexipag film-coated tablets of 50 µg

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2016-04-20
• Last updated: 2025-02-03