Study Details

Relative Bioavailability study of enzalutamide in Prostate Cancer Patients

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01902251

Astellas Study ID

The unique identification code given by the study sponsor.

9785-CL-0003

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Condition

Prostate Cancer, Other

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

18 Years - N/A

Sex

Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Nov 2012 - Oct 2013

Masking

None (Open Label)

Enrollment number

27

A Phase I, open-label, randomized, parallel, relative bioavailability study comparing a capsule and a tablet formulation of Enzalutamide following multiple once daily doses of 160 mg Enzalutamide in male subjects with prostate cancer

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

University of Chicago Medical Center

Chicago, United States, 60637

University of Pittsburgh Medical Center

Pittsburgh, United States, 15232

South Texas Accelerated Research Therapeutics

San Antonio, United States, 78229

University of Colorado - Anschutz Medical Campus

Denver, United States, 80045