Healthy Subjects Clinical Trial
Official title:
A Phase I, Randomized, Open-label, 2-arm Parallel-design Study to Determine the Effect of Multiple-dose Rifampin on the Pharmacokinetics, Safety and Tolerability of Single-dose Enzalutamide in Healthy Male Subjects
This study evaluates how a drug that alters liver enzymes (rifampin) affects the metabolism of enzalutamide in men by measuring concentrations of enzalutamide and its metabolites in plasma.
The study consists of 2 randomized treatment arms. In both arms the subjects receive a
single oral dose of enzalutamide.
In Arm 1 the subjects are admitted to the clinic on Day -1 where they remain until Day 3.
Each subject receives a single oral dose of enzalutamide, administered under fasted
conditions on Day 1. Ambulant visits take place from Day 4 to Day 50. Full PK profiles are
obtained for enzalutamide, Major Inactive Carboxylic Acid Metabolite (M1) and Active
Metabolite N-desmethyl Enzalutamide (M2) from Day 1 up to Day 50 after intake of
enzalutamide.
In Arm 2 each subject receives a once-daily dose of rifampin on Days 1 to 21. On Day 8, a
single oral dose of enzalutamide is administered under fasted conditions concomitantly with
rifampin. Full PK profiles are obtained for enzalutamide, M1 and M2 from Day 8 up to Day 57
after intake of enzalutamide.
An End of Study Visit (ESV) takes place between 7 and 10 days after the last PK sample or
early withdrawal.
Safety assessments are performed throughout the study.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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