Actelion Pharmaceuticals Ltd

act-064992 - macitentan

 

Study ID Status Type Title
AC-055-101 Completed Protocol Summary Investigation of the single ascending dose tolerability, pharmacokinetics, and pharmacodynamics of ACT-064992 in healthy male subjects
AC-055-102 Completed Protocol Summary Double-blind, placebo-controlled, randomized, multiple ascending dose study to investigate the tolerability, safety, pharmacokinetics, and pharmacodynamics of ACT 064992 in healthy male subjects
AC-055-105 Completed Protocol Summary An open-label study to investigate the effect of multiple-dose ACT-064992 on the pharmacokinetics and pharmacodynamics of single-dose warfarin in healthy male subjects
AC-055-106 Completed Protocol Summary An open-label, randomized, three-treatment, three-period, crossover study to investigate mutual drug-drug interactions between ACT 064992 and sildenafil in healthy male subjects.
AC-055-111 Completed Protocol Summary A single-center, open-label, two-part, one-sequence crossover study to investigate the effect of cyclosporine and rifampicin on the pharmacokinetics of macitentan in healthy male subjects
AC-055-112 Completed Protocol Summary Single-center, open-label, phase I study to investigate the pharmacokinetics (PK), tolerability, and safety of a single oral dose of macitentan in subjects with severe renal fuction impairment.
AC-055-114 Completed Protocol Summary A double-blind, randomized, placebo-controlled, four-way crossover Phase 1 study including an open-label positive control (moxifloxacin) to assess the effect of repeated daily doses of 10 mg and 30 mg macitentan on the QT/QTc interval of the ECG in healthy male and female subjects
AC-055-115 Terminated Protocol Summary A Phase 1/1b, open-label study in patients with recurrent glioblastoma to assess the safety and tolerability of macitentan in combination with dose-dense temozolomide
AC-055-116 Completed Protocol Summary A double-blind, randomized, placebo-controlled, Phase 1 study to assess the tolerability, safety and pharmacokinetics of ACT-064992 at a repeated daily dose of 3 mg and 10 mg in Japanese healthy male subjects
AC-055-117 Completed Protocol Summary A double-blind, randomized, placebo-controlled, phase I study to assess the tolerability, safety, pharmacokinetics, and pharmacodynamics of repeated daily doses of 3, 10 and 30mg of Macitentan in Korean healthy male subjects
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