Bioequivalence Study of Abiraterone Acetate Coated and Uncoated Tablet Formulations in Healthy Male Participants

This is a Phase 1, randomized (study medication assigned to participants by chance),
open-label (all people know the identity of the intervention), single-center, single-dose
and 3-way Crossover (the same medications provided to all participants but in different
sequence) pivotal study to determine the bioequivalence of 2 abiraterone acetate coated
tablet formulations with respect to the current commercial abiraterone acetate uncoated
tablet formulation. Approximately 102 healthy male participants will participate in this
study. Participants will be randomly assigned to 1 of 6 treatment sequences. The study will
consist of 3 parts: Screening Phase (within 21 days before the first study drug
administration of the first period), an open-label treatment Phase consisting of 3
single-dose treatment periods (45 days) and follow-up Phase (5 to 7 days after the last
study procedure). The total study duration for each participant will be from 45 days to a
maximum of 61 days. Participants will receive a single oral 1000 milligram (mg) dose of
abiraterone acetate under fasted conditions either as Treatment A (current commercial
formulation, uncoated), Treatment B (current commercial formulation, coated) or Treatment C
(new composition, coated). Bioequivalence will be primarily evaluated by pharmacokinetic
parameters. Participants' safety will be monitored throughout the study.

Inclusion Criteria:

- If sexually active, participants must always use a condom during the study and for 1
week after last intake of study drug. If sexually active with a pregnant woman or
woman of child-bearing potential, participants must agree to abstain from intercourse
during the study and for 1 week after last intake of study drug. Participants should
not donate sperm during the study and for 1 week after receiving the last dose of
study drug

- Body mass index (BMI; weight [kilogram(kg)]/height^2 [meter square (m^2)]) between
18.5 and 30.0 kg/m^2, (inclusive), and body weight not less than 50 kg

- Blood pressure (after the participants is supine for 5 minutes) between 90 and 140
millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg
diastolic at Screening

- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and
function at Screening as specified in the protocol

- Non-smoker, no history of smoking or use of nicotine-containing substances within the
previous 2 months, as determined by medical history or participant's verbal report

Exclusion Criteria:

- History of or current clinically significant medical illness including (but not
limited to) cardiac arrhythmias or other cardiac disease, hematologic disease,
coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid
abnormalities, significant pulmonary disease, including bronchospastic respiratory
disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease,
neurologic or psychiatric disease, infection, or any other illness that the
investigator considers should exclude the participants or that could interfere with
the interpretation of the study results

- Clinically significant abnormal values for hematology or clinical chemistry at
Screening

- Presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any
medical condition that would affect sexual function

- Use of any prescription or nonprescription medication (including vitamins and herbal
supplements), except for acetaminophen, within 14 days before the first dose of the
study drug is scheduled through study completion

- History of, or a reason to believe a participants has a history of drug or alcohol
abuse within the past 5 years