NCT02206204

Study of Selexipag and Its Metabolite ACT-333679 on Cardiac Repolarization in Healthy Male and Female Subjects

Single-center, Double-blind, Randomized, Placebo- and Positive-controlled, Parallel-group With Nested Cross-over, Multiple-dose, Up-titration Study of the Effects of Selexipag and Its Metabolite ACT-333679 on Cardiac Repolarization in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, double-blind, randomized, placebo- and positive-controlled, double-dummy, parallel-group, multiple-dose, up-titration study with a nested cross-over comparison between moxifloxacin and placebo in healthy male and female subjects. The primary objective is to demonstrate that selexipag and its metabolite ACT-333679 do not have an effect on cardiac repolarization exceeding the threshold of regulatory concern, at two orally administered dose levels (800 and 1600 μg twice daily) in healthy male and female subjects. Moxifloxacin is included as a positive control.

Conditions

• Cardiodynamics
• Safety
• Tolerability
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	selexipag
DRUG	placebo for selexipag
DRUG	moxifloxacin
DRUG	moxifloxacin-matching placebo

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2014-08-01
• Last updated: 2014-08-01

Locations

1 site across 1 country: United States