A Study to Evaluate How Daily Dosing With Enzalutamide Affects the Metabolism of Caffeine and Dextromethorphan in Men With Prostate Cancer

• Status: Completed
• Trial end date: 2014-02-03
• Target enrollment: 0
• Participant gender: Male

Summary

This study evaluates how once daily enzalutamide affects the metabolism of caffeine and dextromethorphan in men with prostate cancer by measuring concentrations of these drugs and their metabolites in plasma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Europe B.V.
• Collaborator: Medivation, Inc.
• Treatments: Caffeine; Dextromethorphan

Criteria

Inclusion Criteria:

• Subject is a male aged 18 years old or older (at screening) with histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant setting). Subjects may be on ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or have undergone prior bilateral orchiectomy at screening.

• Subject has progressive disease by prostate-specific antigen (PSA) or imaging.

• Subject has received no more than 2 prior chemotherapy regimens.

• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

• Male subject must use a condom if having sex with a pregnant woman.

• Male subject and their female spouse/partners who are of childbearing potential must use 2 acceptable methods of birth control starting at screening and continuing throughout the study period and for 3 months after final study drug administration.

• Subject has an estimated life expectancy of at least 6 months.

Exclusion Criteria:

• Subject has confirmed CYP2D6 poor metabolizer, or CYP2D6 ultrarapid metabolizer status based on genotyping analysis.

• Subject has known metastases in the liver or any hepatic disorder that could affect drug metabolism deemed clinically significant by the investigator after discussion with the sponsor.

• Subject has undergone major surgery within 4 weeks prior to day 1.

• Subject received treatment with chemotherapy within 4 weeks prior to enrollment (day 1 visit) or plans to initiate treatment with chemotherapy during the study.

• Subject uses concomitant medications that are potent inducers and/or inhibitors of CYP1A2, CYP2C8, CYP2D6, or CYP3A4.