A Study to Evaluate the Pharmacokinetics of Abiraterone in Healthy Chinese Male Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate after oral administration of abiraterone acetate at different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under fasted conditions.

Detailed Description
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This is an open-label (all people know the identity of the intervention), randomized (the treatment sequence is assigned by chance), 3-way crossover study (method used to switch participants from one dose level to another in a clinical study) of single doses of abiraterone acetate in healthy Chinese male participants. The study consists of 3 phases: screening, open-label treatment, and follow up phases. After screening, randomly assigned participants will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to a randomized schedule under fasted conditions (Sequence 1 = ABC; Sequence 2 = BAC; and Sequence 3 = CBA). Each treatment period will be separated by a washout period (period when participant is not receiving any study medication) of at least 7 days. In the follow-up phase, study-related adverse events will be monitored by the investigator. Serial blood samples for pharmacokinetic analysis will be collected and safety will be monitored throughout the study. The total study duration will be approximately 42 days.

Official Title
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A Single-Dose, Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Pharmacokinetics of Abiraterone in Chinese Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Treatment A: abiraterone acetate
* Drug: Treatment B: abiraterone acetate
* Drug: Treatment C: abiraterone acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index within 18 to 27 kg/m2 (inclusive) and body weight above 50 kg at screening Protocol-defined laboratory and electrocardiogram parameters Negative test results for selected medications and substances of abuse and negative exhaled carbon monoxide test at check-in day of each period Agrees to protocol-defined use of effective contraception Willing to be confined at the clinical research facility for time period specified in the protocol Exclusion Criteria: Significant history or current manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder History of hypersensitivity reaction to the study medication or related compounds or excipients used in the formulation Confirmed hepatitis A, B, or C infection or human immunodeficiency virus (HIV) 1 or HIV-2 infection at screening Serum testosterone level of <200 ng/dL Use of any tobacco or nicotine-containing products Known or suspected use of illicit drugs in the last year Protocol contraindicated medications/preparations (prescription and non-prescription)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1: abiraterone acetate<br>Randomly assigned participants in Sequence 1 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule ABC under fasted conditions. | Drug: Treatment A: abiraterone acetate<br>* 250 mg/day tablet administered orally on Day 1 of each treatment period.<br>* Other names: ZYTIGA;Drug: Treatment B: abiraterone acetate<br>* 500 mg/day tablets administered orally on Day 1 of each treatment period.<br>* Other names: ZYTIGA;Drug: Treatment C: abiraterone acetate<br>* 1000 mg/day tablets administered orally on Day 1 of each treatment period.<br>* Other names: ZYTIGA;|
| Experimental: Sequence 2: abiraterone acetate<br>Randomly assigned participants in Sequence 2 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule BAC under fasted conditions. | Drug: Treatment A: abiraterone acetate<br>* 250 mg/day tablet administered orally on Day 1 of each treatment period.<br>* Other names: ZYTIGA;Drug: Treatment B: abiraterone acetate<br>* 500 mg/day tablets administered orally on Day 1 of each treatment period.<br>* Other names: ZYTIGA;Drug: Treatment C: abiraterone acetate<br>* 1000 mg/day tablets administered orally on Day 1 of each treatment period.<br>* Other names: ZYTIGA;|
| Experimental: Sequence 3: abiraterone acetate<br>Randomly assigned participants in Sequence 3 will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to the randomized schedule CBA under fasted conditions. | Drug: Treatment A: abiraterone acetate<br>* 250 mg/day tablet administered orally on Day 1 of each treatment period.<br>* Other names: ZYTIGA;Drug: Treatment B: abiraterone acetate<br>* 500 mg/day tablets administered orally on Day 1 of each treatment period.<br>* Other names: ZYTIGA;Drug: Treatment C: abiraterone acetate<br>* 1000 mg/day tablets administered orally on Day 1 of each treatment period.<br>* Other names: ZYTIGA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration of abiraterone |  | Pre-dose and up to 96 hours post-dose each treatment period | 
| Time to reach the maximum observed plasma concentration of abiraterone |  | Pre-dose and up to 96 hours post-dose each treatment period | 
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of abiraterone |  | Pre-dose and up to 96 hours post-dose each treatment period | 
| Area under the plasma concentration-time curve extrapolated to infinite time of abiraterone |  | Pre-dose and up to 96 hours post-dose each treatment period | 
| Apparent terminal elimination rate constant of abiraterone |  | Pre-dose and up to 96 hours post-dose each treatment period | 
| Apparent terminal elimination half-life of abiraterone |  | Pre-dose and up to 96 hours post-dose each treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Up to 42 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, Pharmacokinetics, Abiraterone acetate, Abiraterone, JNJ-212082, Zytiga, Chinese, Fasted