NCT02138799

A Study to Evaluate How a Drug That Alters Liver Enzymes (Rifampin) Affects the Metabolism of Enzalutamide in Men

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Drug-Drug Interaction (DDI)
• Healthy Subjects
• Pharmacokinetics of Enzalutamide

Interventions

Type	Name	Description
DRUG	enzalutamide	oral
DRUG	rifampin	oral

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2014-05-15
• Last updated: 2014-10-15

Locations

1 site across 1 country: Germany