Study of Selexipag and Its Metabolite ACT-333679 on Cardiac Repolarization in Healthy Male and Female Subjects
Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Actelion
Treatments:
Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination Selexipag