Study Phase 1

A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of Macitentan at Steady State on the Pharmacokinetics of Rosuvastatin in Healthy Male Subjects.

Trial Information

Generic NameMacitentanProduct NameOPSUMIT®Therapeutic AreaRespiratory Tract (Lung and Bronchial) DiseasesEnrollment20% Female0.0%% White95%
Product ClassEndothelin Receptor AntagonistSponsor Protocol NumberAC-055-122Data PartnerJohnson & JohnsonCondition StudiedPulmonary Arterial HypertensionMean/Median Age (Years)38.5

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

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