A Phase 1, Single Dose, Open-Label, Three-Period, Crossover Study to Determine the Effect of Food on the Pharmacokinetics of Abiraterone Acetate in Healthy Male Subjects

Cougar Biotechnology, Inc.0 sites36 target enrollmentSeptember 2009

ConditionsHealthy Volunteers

DrugsTreatment A: abiraterone acetate Treatment B: abiraterone acetate Treatment C: abiraterone acetate

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy Volunteers
Sponsor: Cougar Biotechnology, Inc.
Enrollment: 36
Primary Endpoint: Maximum observed concentration of abiraterone
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the effect of food on the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate 1000 mg when administered as a single dose in healthy male volunteers.

Detailed Description

This is an open-label (identity of assigned study drug will be known), randomized (treatment sequences will be assigned by chance) study of a single dose of abiraterone acetate 1000 mg administered orally (by mouth) in approximately 36 healthy male participants under fasted and fed conditions. Three doses of abiraterone acetate will be administered with a 7-day washout period between each dose. The total study duration for each participant will be 21 days. Participants will be randomized to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA): Treatment A = abiraterone acetate 1000 mg administered after a high-fat meal; Treatment B = abiraterone acetate 1000 mg administered after a low-fat meal; Treatment C = abiraterone acetate 1000 mg administered in the fasted state. No food will be ingested for 4 hours post-dose. Participants will be confined at the clinical research unit from the day prior to dosing until clinic discharge on the day following dosing in each treatment period. Serial pharmacokinetic samples will be collected and safety will be monitored throughout the study.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

October 2009

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Cougar Biotechnology, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•In good general health as determined by no clinically significant findings on medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory measurements
•Body mass index within 18 kg/m2 to 32 kg/m2, inclusive
•Non-tobacco users
•Clinical laboratory values within protocol-defined parameters
•Negative hepatitis panel (including hepatitis B surface antigen \[HBsAg\] and hepatitis C virus antibody \[anti-HCV\]),and negative human immunodeficiency virus (HIV) antibody screens
•Negative test for selected drugs of abuse
•Agrees to protocol-defined use of effective contraception

Exclusion Criteria

•Significant history or manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological or psychiatric disorder, as determined by the Principal Investigator
•History or presence of an abnormal electrocardiogram
•History of stomach or intestinal surgery resection that would potentially alter absorption and/or excretion of orally administered drugs
•Screening serum total testosterone of \<200 ng/dL
•History of hypersensitivity reaction to the study drug, related compounds or excipients used in the formulation
•Receipt of an investigational drug within 5 half-lives or 30 days prior to Day -1, whichever is longer
•Abnormal diet during the 30 days prior to Day 1
•Donation of blood or significant loss of blood within 56 days or plasma within 14 days prior to Day -1
•Planned donation of blood or plasma from Screening through Study Completion, Day 21
•Receipt of blood products within 2 months prior to Day 1