A Study to Evaluate the Pharmacokinetics of Abiraterone in Healthy Chinese Male Participants
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ClinicalTrials.gov Identifier: NCT01678573 |
Recruitment Status :
Completed
First Posted : September 5, 2012
Last Update Posted : September 6, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Treatment A: abiraterone acetate Drug: Treatment B: abiraterone acetate Drug: Treatment C: abiraterone acetate | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Single-Dose, Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Pharmacokinetics of Abiraterone in Chinese Healthy Male Subjects |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | September 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Sequence 1: abiraterone acetate
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.
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Drug: Treatment A: abiraterone acetate
250 mg/day tablet administered orally on Day 1 of each treatment period.
Other Name: ZYTIGA Drug: Treatment B: abiraterone acetate 500 mg/day tablets administered orally on Day 1 of each treatment period.
Other Name: ZYTIGA Drug: Treatment C: abiraterone acetate 1000 mg/day tablets administered orally on Day 1 of each treatment period.
Other Name: ZYTIGA |
Experimental: Sequence 2: abiraterone acetate
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
250 mg/day tablet administered orally on Day 1 of each treatment period.
Other Name: ZYTIGA Drug: Treatment B: abiraterone acetate 500 mg/day tablets administered orally on Day 1 of each treatment period.
Other Name: ZYTIGA Drug: Treatment C: abiraterone acetate 1000 mg/day tablets administered orally on Day 1 of each treatment period.
Other Name: ZYTIGA |
Experimental: Sequence 3: abiraterone acetate
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
250 mg/day tablet administered orally on Day 1 of each treatment period.
Other Name: ZYTIGA Drug: Treatment B: abiraterone acetate 500 mg/day tablets administered orally on Day 1 of each treatment period.
Other Name: ZYTIGA Drug: Treatment C: abiraterone acetate 1000 mg/day tablets administered orally on Day 1 of each treatment period.
Other Name: ZYTIGA |
- Maximum observed plasma concentration of abiraterone [ Time Frame: Pre-dose and up to 96 hours post-dose each treatment period ]
- Time to reach the maximum observed plasma concentration of abiraterone [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Pre-dose and up to 96 hours post-dose each treatment period ]
- Apparent terminal elimination rate constant of abiraterone [ Time Frame: Pre-dose and up to 96 hours post-dose each treatment period ]
- Apparent terminal elimination half-life of abiraterone [ Time Frame: Pre-dose and up to 96 hours post-dose each treatment period ]
- Number of participants with adverse events [ Time Frame: Up to 42 days ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678573
China | |
Beijing, China |
Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT01678573 |
Other Study ID Numbers: |
CR100668 ABI-PRO-1016 ( Other Identifier: Janssen Research & Development, LLC ) |
First Posted: | September 5, 2012 Key Record Dates |
Last Update Posted: | September 6, 2013 |
Last Verified: | September 2013 |
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