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

Trial Profile

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

Completed
Phase of Trial: Phase I

Latest Information Update: 27 Jun 2017

At a glance

  • Drugs Selexipag (Primary)
  • Indications Arteriosclerosis obliterans; Pulmonary arterial hypertension; Pulmonary hypertension; Raynaud's disease
  • Focus Pharmacokinetics
  • Sponsors Actelion Pharmaceuticals
  • Most Recent Events

    • 27 Jun 2017 Primary endpoint (Maximum plasma concentration (Cmax) of selexipag) has not been met as per the results presented at the 13th Congress of the European Association for Clinical Pharmacology and Therapeutics
    • 27 Jun 2017 Primary endpoint (Maximum plasma concentration (Cmax) of ACT-333679) has been met as per the results presented at the 13th Congress of the European Association for Clinical Pharmacology and Therapeutics
    • 27 Jun 2017 Primary endpoint (Area under plasma concentration-time curve [AUC(0-inf)] of selexipag and ACT-333679) has been met as per the results presented at the 13th Congress of the European Association for Clinical Pharmacology and Therapeutics
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