A Study to Assess the Relative Bioavailability of 4 New Abiraterone Acetate Tablet Formulations With Respect to the Current Commercial Abiraterone Acetate Tablet Under Fasted Conditions in Healthy Male Participants

This is a randomized (individuals will be assigned by chance to study treatments),
open-label (individuals will know the identity of study treatments), 4-period, 5-treatment
crossover study in order to evaluate the relative bioavailability of 4 new formulations of
abiraterone acetate compared to the current commercial formulation. Approximately 32 healthy
adult males will participate. The total study length is up to 68 days. This study will
consist of a screening phase followed by an open-label treatment phase consisting of 4
single-dose treatment periods separated by a washout period of at least 7 days between
dosing. Individuals will be randomly assigned to 1 of 8 treatment sequences. A single dose
of 1000 mg abiraterone acetate will be given in each treatment period under fasted
conditions. Participants will be confined to the study center from Day -1 of each treatment
period until completion of the 96-hour blood sample collection on Day 5 of each treatment
period. A follow-up visit will occur between 5 to 7 days after the last study procedure.
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.

Inclusion Criteria:

- Agrees to protocol-defined use of effective contraception for up to 1 week after
receiving the last dose of study drug and agrees to not donate sperm during the study
and for 1 week after receiving the last dose of study drug

- Body mass index between 18.5 and 30.0 kg/m2 (inclusive) and body weight not less than
50 kg

- Blood pressure (after lying down for 5 minutes) between 90 and 140 mmHg systolic and
no higher than 90 mmHg diastolic

- A 12-lead electrocardiogram consistent with normal cardiac conduction and function

- Non-smoker and no use of nicotine-containing substances within the previous 2 months

- Laboratory values within protocol-defined parameters

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, 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 patient or that
could interfere with the interpretation of the study results

- Clinically significant abnormal values for hematology, clinical chemistry,
urinalysis, or clinically significant abnormal physical examination, vital signs, or
12-lead electrocardiogram at screening or at admission to the study center as deemed
appropriate by the investigator

- Screening serum testosterone level of <200 ng/dL

- Presence of sexual dysfunction 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 participant has a history of drug or alcohol
abuse within the past 5 years

- Positive test for drugs of abuse (such as cannabinoids, alcohol, opiates, cocaine,
amphetamines, benzodiazepines, hallucinogens, or barbiturates) at screening and Day
-1 of each treatment period

- Known allergy to the study drug or any of the excipients of the formulation

- History of stomach or intestinal surgery or resection that would potentially alter
absorption or excretion of orally administered drugs (appendectomy and hernia repair
will be allowed)

- Donated blood or blood products or had substantial loss of blood within 3 months
before the first administration of study drug or intention to donate blood or blood
products during the study

- Received an experimental drug or used an experimental medical device within 1 month
or within a period less than 10 times the drug's half-life, whichever is longer,
before the first dose of the study drug is scheduled

- Unable to swallow solid, oral dosage forms whole with the aid of water

- Positive test for human immunodeficiency virus 1 and 2 antibodies, hepatitis B
surface antigen, hepatitis B core antibody, or hepatitis C antibodies

- Preplanned surgery or procedures that would interfere with the conduct of the study