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

NCT02225093 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-06-27

No results posted yet for this study

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.

Conditions

  • Pharmacokinetics of Dextromethorphan
  • Pharmacokinetics of Caffeine
  • Prostate Cancer

Interventions

DRUG

Caffeine

Oral

DRUG

Dextromethorphan

Oral /.L

DRUG

Enzalutamide

Oral

DRUG

Enzalutamide Placebo to Match (PTM)

Oral

Sponsors & Collaborators

  • Medivation, Inc.

    collaborator INDUSTRY

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Astellas Pharma Europe B.V.

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-02
Primary Completion
2014-02-03
Completion
2014-02-03

Countries

  • Moldova

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02225093 on ClinicalTrials.gov