MedTrace Logo

A Study to Assess the Effect of Abiraterone Acetate in Male Participants With Mild or Moderate Hepatic Impairment Compared to Matched Control Participants With Normal Hepatic Function

NCT02001571 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-12-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics (study of what the body does to a drug) of 1000 mg oral dose of abiraterone acetate and its major metabolite(s) with mild or moderate hepatic impairment and matched control Participants with normal hepatic function.

Conditions

Interventions

DRUG

Abiraterone acetate

On the morning of Day 1, each participant was given four 250 mg tablets of abiraterone acetate with 240 mL of room temperature tap water. Dosing followed at least a 10-hour fast from food (not including water).

Sponsors & Collaborators

  • Cougar Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Cougar Biotechnology, Inc. Clinical Trial · Cougar Biotechnology, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02001571 on ClinicalTrials.gov