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A Study to Assess the Effect of Timing of Food Intake on the Pharmacokinetics of Abiraterone Following Single-Dose Administration of Abiraterone Acetate Tablets in Healthy Caucasian and Japanese Men

This study has been completed.
Sponsor:
Information provided by:
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01575587
First received: January 19, 2012
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the effect of timing of food intake on systemic abiraterone exposure observed in healthy adult Japanese and Caucasian men.


Condition Intervention Phase
Pharmacology
 Drug: Abiraterone: Treatment A
Drug: Abiraterone: Treatment B
Drug: Abiraterone: Treatment C
Drug: Abiraterone: Treatment D
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-Dose, Open-Label, Randomized, 4-Way Crossover Study to Assess the Effect of Timing of Food Intake on the Pharmacokinetics of Abiraterone Following Single-Dose Administration of Abiraterone Acetate Tablets in Healthy Caucasian and Japanese Male Subjects

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Changes in mean plasma concentrations of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean plasma concentrations of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
  • Maximum plasma concentration of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
  • Time to reach the maximum plasma concentration of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentration of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
  • Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
  • First-order rate constant associated with the terminal portion of the curve of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
  • Time to last quantifiable plasma concentration of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
  • Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
  • The number of participants affected by an adverse event [ Time Frame: Up to the end of the study (4 days after final dose of study drug) or early withdrawal ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A Drug: Abiraterone: Treatment A
1000 mg abiraterone acetate administered in the fasting state
Experimental: Treatment B Drug: Abiraterone: Treatment B
Standardized meal administered 1 hour after the 1000 mg abiraterone acetate dose
Experimental: Treatment C Drug: Abiraterone: Treatment C
Standardized meal administered 2 hours before the 1000 mg abiraterone acetate dose
Experimental: Treatment D Drug: Abiraterone: Treatment D
Standardized meal administered 2 hours before and 2 hours after the 1000 mg abiraterone acetate dose

Detailed Description:

This is a randomized (individuals will be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), single dose, 4-way crossover study of abiraterone acetate in approximately 48 healthy adult Japanese and Caucasian men. For the crossover design, the treatment sequences are defined as follows: 1 - ADBC, 2 - BACD, 3 - CBDA, and 4 - DCAB; where Treatment A = abiraterone acetate administered in the fasted state, Treatment B = standardized meal administered 1 hour after abiraterone acetate dose, Treatment C = standardized meal administered 2 hours after abiraterone acetate dose, and Treatment D = standardized meal administered 2 hours before and 2 hours after abiraterone acetate dose. This study will consist of a screening period followed by four open-label treatment periods separated by a washout period of at least 14 days between dosing. Eligible participants will be randomly assigned on Day 1 to 1 of 4 treatment sequences that differ with regard to timing of food intake before and/or after dosing with a single dose of 1000 mg of abiraterone acetate. 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. End-of-study assessments will be performed on Day 4 of Period 4 or upon early withdrawal.

  Eligibility

Ages Eligible for Study:   25 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy Caucasian and Japanese male individuals.
  • Body mass index between 18 and 30 kg/m2.
  • Body weight >=50 kg.
  • A normal 12-lead electrocardiogram.

Exclusion Criteria:

  • History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
  • Presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any medical condition that would affect sexual function.
  • History of alcohol consumption of more than 4 drinks daily within 1 year prior to screening and unwillingness to abstain from alcohol-containing food or beverages from within 24 hours before Day-1 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 human immunodeficiency virus 1 and 2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies.
  • History of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or participant's verbal report.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575587

Locations
United States, California
Cypress, California, United States
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: Director Clinical Research, Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01575587     History of Changes
Other Study ID Numbers: CR100737, 212082PCR1005
Study First Received: January 19, 2012
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Pharmacology
Pharmacokinetics
Pharmacodynamics
Abiraterone acetate
 Food intake
Caucasion
Japanese
Healthy

ClinicalTrials.gov processed this record on May 22, 2013