A Study to Evaluate the Pharmacokinetics of Abiraterone in Healthy Chinese Male Participants - Full Text View

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Treatment A: abiraterone acetate Drug: Treatment B: abiraterone acetate Drug: Treatment C: abiraterone acetate	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Abiraterone acetate

U.S. FDA Resources

Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:

Maximum observed plasma concentration of abiraterone [ Time Frame: Pre-dose and up to 96 hours post-dose each treatment period ] [ Designated as safety issue: No ]
Time to reach the maximum observed plasma concentration of abiraterone [ Time Frame: Pre-dose and up to 96 hours post-dose each treatment period ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Apparent terminal elimination rate constant of abiraterone [ Time Frame: Pre-dose and up to 96 hours post-dose each treatment period ] [ Designated as safety issue: No ]
Apparent terminal elimination half-life of abiraterone [ Time Frame: Pre-dose and up to 96 hours post-dose each treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of participants with adverse events [ Time Frame: Up to 42 days ] [ Designated as safety issue: Yes ]

Enrollment:	15
Study Start Date:	July 2012
Study Completion Date:	September 2012
Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678573

Locations

China

Beijing, China

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

Study Director:

Janssen Research & Development, LLC Clinical Trial

Janssen Research & Development, LLC

More Information

No publications provided

Responsible Party:	Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:	NCT01678573 History of Changes
Other Study ID Numbers:	CR100668, ABI-PRO-1016
Study First Received:	August 31, 2012
Last Updated:	March 1, 2013
Health Authority:	China: Food and Drug Administration United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:

Healthy
Pharmacokinetics
Abiraterone acetate
Abiraterone

JNJ-212082
Zytiga
Chinese
Fasted

ClinicalTrials.gov processed this record on May 19, 2013