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

NCT ID: NCT01678573

Last Updated: 2013-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-09-30

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.

Conditions

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Healthy

Keywords

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Healthy Pharmacokinetics Abiraterone acetate Abiraterone JNJ-212082 Zytiga Chinese Fasted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Treatment A: abiraterone acetate

Intervention Type DRUG

250 mg/day tablet administered orally on Day 1 of each treatment period.

Treatment B: abiraterone acetate

Intervention Type DRUG

500 mg/day tablets administered orally on Day 1 of each treatment period.

Treatment C: abiraterone acetate

Intervention Type DRUG

1000 mg/day tablets administered orally on Day 1 of each treatment period.

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.

Group Type EXPERIMENTAL

Treatment A: abiraterone acetate

Intervention Type DRUG

250 mg/day tablet administered orally on Day 1 of each treatment period.

Treatment B: abiraterone acetate

Intervention Type DRUG

500 mg/day tablets administered orally on Day 1 of each treatment period.

Treatment C: abiraterone acetate

Intervention Type DRUG

1000 mg/day tablets administered orally on Day 1 of each treatment period.

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.

Group Type EXPERIMENTAL

Treatment A: abiraterone acetate

Intervention Type DRUG

250 mg/day tablet administered orally on Day 1 of each treatment period.

Treatment B: abiraterone acetate

Intervention Type DRUG

500 mg/day tablets administered orally on Day 1 of each treatment period.

Treatment C: abiraterone acetate

Intervention Type DRUG

1000 mg/day tablets administered orally on Day 1 of each treatment period.

Interventions

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Treatment A: abiraterone acetate

250 mg/day tablet administered orally on Day 1 of each treatment period.

Intervention Type DRUG

Treatment B: abiraterone acetate

500 mg/day tablets administered orally on Day 1 of each treatment period.

Intervention Type DRUG

Treatment C: abiraterone acetate

1000 mg/day tablets administered orally on Day 1 of each treatment period.

Intervention Type DRUG

Other Intervention Names

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ZYTIGA ZYTIGA ZYTIGA

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Beijing, , China

Site Status

Countries

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China

Other Identifiers

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ABI-PRO-1016

Identifier Type: OTHER

Identifier Source: secondary_id

CR100668

Identifier Type: -

Identifier Source: org_study_id