A Study to Assess the Effect of Timing of Food Intake on the Pharmacokinetics of Abiraterone Following Single-Dose Administration of Abiraterone Acetate Tablets in Healthy Caucasian and Japanese Men

• Mean plasma concentrations of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
• Maximum plasma concentration of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
• Time to reach the maximum plasma concentration of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
• Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentration of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
• Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
• Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
• First-order rate constant associated with the terminal portion of the curve of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
• Time to last quantifiable plasma concentration of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
• Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
• The number of participants affected by an adverse event [ Time Frame: Up to the end of the study (4 days after final dose of study drug) or early withdrawal ] [ Designated as safety issue: Yes ]

The purpose of this study is to evaluate the effect of timing of food intake on systemic abiraterone exposure observed in healthy adult Japanese and Caucasian men.

This is a randomized (individuals will be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), single dose, 4-way crossover study of abiraterone acetate in approximately 48 healthy adult Japanese and Caucasian men. For the crossover design, the treatment sequences are defined as follows: 1 - ADBC, 2 - BACD, 3 - CBDA, and 4 - DCAB; where Treatment A = abiraterone acetate administered in the fasted state, Treatment B = standardized meal administered 1 hour after abiraterone acetate dose, Treatment C = standardized meal administered 2 hours after abiraterone acetate dose, and Treatment D = standardized meal administered 2 hours before and 2 hours after abiraterone acetate dose. This study will consist of a screening period followed by four open-label treatment periods separated by a washout period of at least 14 days between dosing. Eligible participants will be randomly assigned on Day 1 to 1 of 4 treatment sequences that differ with regard to timing of food intake before and/or after dosing with a single dose of 1000 mg of abiraterone acetate. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected during the open-label treatment phase as detailed in the protocol. Safety will be monitored throughout the study. End-of-study assessments will be performed on Day 4 of Period 4 or upon early withdrawal.

• Drug: Abiraterone: Treatment A
  1000 mg abiraterone acetate administered in the fasting state
• Drug: Abiraterone: Treatment B
  Standardized meal administered 1 hour after the 1000 mg abiraterone acetate dose
• Drug: Abiraterone: Treatment C
  Standardized meal administered 2 hours before the 1000 mg abiraterone acetate dose
• Drug: Abiraterone: Treatment D
  Standardized meal administered 2 hours before and 2 hours after the 1000 mg abiraterone acetate dose

• Experimental: Treatment A
  Intervention: Drug: Abiraterone: Treatment A
• Experimental: Treatment B
  Intervention: Drug: Abiraterone: Treatment B
• Experimental: Treatment C
  Intervention: Drug: Abiraterone: Treatment C
• Experimental: Treatment D
  Intervention: Drug: Abiraterone: Treatment D

Inclusion Criteria:

• Healthy Caucasian and Japanese male individuals.
• Body mass index between 18 and 30 kg/m2.
• Body weight >=50 kg.
• A normal 12-lead electrocardiogram.

Exclusion Criteria:

• History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
• Presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any medical condition that would affect sexual function.
• History of alcohol consumption of more than 4 drinks daily within 1 year prior to screening and unwillingness to abstain from alcohol-containing food or beverages from within 24 hours before Day-1 through study completion.
• History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years.
• Positive test for human immunodeficiency virus 1 and 2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies.
• History of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or participant's verbal report.