- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01575587
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
January 9, 2014 updated by: Janssen Research & Development, LLC
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
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Cypress, California, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment B
|
Standardized meal administered 1 hour after the 1000 mg abiraterone acetate dose
|
Experimental: Treatment C
|
Standardized meal administered 2 hours before the 1000 mg abiraterone acetate dose
|
Experimental: Treatment A
|
1000 mg abiraterone acetate administered in the fasting state
|
Experimental: Treatment D
|
Standardized meal administered 2 hours before and 2 hours after the 1000 mg abiraterone acetate dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in mean plasma concentrations of abiraterone
Time Frame: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean plasma concentrations of abiraterone
Time Frame: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
Maximum plasma concentration of abiraterone
Time Frame: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
Time to reach the maximum plasma concentration of abiraterone
Time Frame: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
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
|
Up to Day 4, treatment period 4
|
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
Time Frame: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
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
|
Up to Day 4, treatment period 4
|
First-order rate constant associated with the terminal portion of the curve of abiraterone
Time Frame: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
Time to last quantifiable plasma concentration of abiraterone
Time Frame: Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
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
|
Up to Day 4, treatment period 4
|
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
|
Up to the end of the study (4 days after final dose of study drug) or early withdrawal
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
January 19, 2012
First Submitted That Met QC Criteria
April 10, 2012
First Posted (Estimate)
April 11, 2012
Study Record Updates
Last Update Posted (Estimate)
January 10, 2014
Last Update Submitted That Met QC Criteria
January 9, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CR100737
- 212082PCR1005 (Other Identifier: Janssen Research & Development, LLC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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