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A Pharmacokinetics Study to Assess Abiraterone Acetate Capsule and Tablet Formulations in Patients With Prostate Cancer

NCT00600535 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2013-04-17

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of capsule and tablet formulations of CB7630 (abiraterone acetate) taken with and without food in patients with prostate cancer.

Conditions

  • Prostate Neoplasms

Interventions

DRUG

Stage 1 Group 1: abiraterone acetate

1000 mg capsules/day orally on Day 1. On Day 8, patients will crossover and receive tablet formulation at the same dose.

DRUG

Stage 1 Group 2: abiraterone acetate

1000 mg tablets/day orally on Day 1. On Day 8, patients will crossover and receive capsule formulation at the same dose.

DRUG

Stage 2: abiraterone acetate

1000 mg tablets/day orally for 12 cycles (28 days/cycle) according to assigned group from Stage 1.

DRUG

Stage 3: abiraterone acetate

1000 mg tablets/day orally for 12 cycles (28 days/cycle).

DRUG

Stage 3: glucocorticoid

prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for 12 cycles (28 days/cycle).

DRUG

Stage 4: abiraterone acetate

1000 mg tablets/day orally for up to 24 cycles (28 days/cycle).

DRUG

Stage 4: glucocorticoid

prednisone/prednisolone 5 mg twice daily orally or dexamethasone 0.5 mg once daily for up to 24 cycles (28 days/cycle).

Sponsors & Collaborators

  • Cougar Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Cougar Biotechnology Clinical Trial · Cougar Biotechnology, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States
  • United Kingdom

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 NCT00600535 on ClinicalTrials.gov