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A Study to Assess the Relative Bioavailability of 4 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Participants

NCT01897389 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2014-12-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the relative bioavailability of 4 new formulations of abiraterone acetate compared to the current commercial formulation.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Treatment A

1000 mg abiraterone acetate (4 250-mg tablets - current commercial formulation, reference drug) administered as a single oral dose under fasted conditions

DRUG

Treatment B

1000 mg abiraterone acetate (4 250-mg tablets - new formulation) administered as a single oral dose under fasted conditions

DRUG

Treatment C

1000 mg abiraterone acetate (2 500-mg tablets - new formulation) administered as a single oral dose under fasted conditions

DRUG

Treatment D

1000 mg abiraterone acetate (4 250-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions

DRUG

Treatment E

1000 mg abiraterone acetate (2 500-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

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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 NCT01897389 on ClinicalTrials.gov