Actelion Pharmaceuticals Ltd

act-293987 - selexipag

 

Study ID Status Type Title
AC-065-101 Completed Protocol Summary A single-center, randomized, placebo-controlled, double-blind, multiple-period, multiple-ascending-dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of oral ACT-293987 in healthy male subjects
AC-065-104 Completed Protocol Summary A single-center, open-label, single-dose phase 1 study to investigate the pharmacokinetics, tolerability, and safety of 400 µg ACT-293987 in subjects with mild, moderate, or severe hepatic impairment compared to healthy subjects.
AC-065-105 Completed Protocol Summary Single-center, open-label study to investigate the pharmacokinetics, safety, and tolerability of a single oral dose of selexipag in subjects with renal function impairment.
AC-065-106 Completed Protocol Summary 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
AC-065-108 Completed Protocol Summary A single-center, open-label, randomized, two-period, two-treatment, crossover study in healthy male subjects to demonstrate bioequivalence of 1600 μg selexipag administered as eight tablets of 200 μg (reference drug) or as single tablet of 1600 μg (test drug)
AC-065-109 Completed Protocol Summary A single-center, randomized, open-label, 2-treatment, 2-period, crossover study to assess the effects of Kaletra® (lopinavir/ritonavir) on the pharmacokinetics of selexipag (ACT-293987) in healthy male subjects
AC-065-110 Completed Protocol Summary 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
AC-065-112 Completed Protocol Summary 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
AC-065-113 Completed Protocol Summary A single-center, open-label, randomized, two-part, two-treatment, two-period crossover study to investigate the effect of gemfibrozil or rifampicin on the pharmacokinetics of selexipag and its metabolite ACT-333679 in healthy male subjects.
AC-065-114 Completed Protocol Summary A single-center, open-label, randomized, two-treatment crossover study to investigate the effect of selexipag on the pharmacokinetics of midazolam and its metabolite 1-hydroxymidazolam in healthy male subjects
1 2 3