Actelion Pharmaceuticals Ltd

act-128800 - ponesimod

 

Study ID Status Type Title
AC-058-101 Completed Protocol Summary Double-blind, placebo-controlled, randomized, single ascending dose study to investigate the tolerability, safety, pharmacokinetics (including food interaction), and pharmacodynamics of ACT-128800 in healthy male subjects.
AC-058-102 Completed Protocol Summary Single-center, double-blind, placebo-controlled, randomized, ascending multiple-dose study to investigate the tolerability, safety, pharmacokinetics, and pharmacodynamics of ACT-128800 in healthy male and female subjects
AC-058-103 Completed Protocol Summary Single-center, open-label, two-period, two-treatment, randomized, crossover study in healthy male subjects to investigate the pharmacokinetics of the polymorphic forms A and C of ACT-128800
AC-058-104 Completed Protocol Summary Single-center, open-label, two-period, two-treatment, randomized, crossover study to investigate the effect of multiple-dose ACT-128800 on the pharmacokinetics of a single dose of Ortho-Novum® 1/35 in healthy female subjects
AC-058-105 Completed Protocol Summary A single-center, open-label, randomized, multiple-dose, 3-treatment, 3-way crossover study to investigate the effects on heart rate and rhythm of 3 different up-titration regimens of ACT-128800, and of re-initiation of treatment in healthy male and female subjects
AC-058-106 Completed Protocol Summary Single-center, open-label study with 14C-labeled ACT-128800 to investigate the mass balance, pharmacokinetics, and metabolism following single oral administration to healthy male subjects
AC-058-107 Completed Protocol Summary Single-center, open-label, parallel-group study to evaluate the pharmacokinetics, tolerability, and safety of a single dose of 40 mg ACT-128800 in Japanese and Caucasian healthy male and female subjects
AC-058-108 Completed Protocol Summary Single-center, open-label, two-period, two-treatment, randomized, crossover study in healthy male and female subjects to compare the pharmacokinetics of 40 mg capsules and tablets of ACT-128800
AC-058-109 Completed Protocol Summary Single-center, double-blind, placebo-controlled, randomized, parallel-group, up-titration study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of increasing doses of ACT-128800 in healthy male and female subjects
AC-058-110 Completed Protocol Summary A single-center, double-blind, randomized, placebo- and positive-controlled, parallel-group, multiple-dose, up-titration study of the electrocardiographic effects of ponesimod in healthy male and female subjects
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