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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacology
Keywords: Pharmacology
Pharmacokinetics
Pharmacodynamics
Abiraterone acetate
Food intake
Caucasion
Japanese
Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-04-11
Enrollment: 51
Sex: MALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Changes in mean plasma concentrations of abiraterone
timeFrame: Up to Day 4, treatment period 4
Secondary outcomes:
measure: Mean plasma concentrations of abiraterone
timeFrame: Up to Day 4, treatment period 4
measure: Maximum plasma concentration of abiraterone
timeFrame: Up to Day 4, treatment period 4
measure: Time to reach the maximum plasma concentration of abiraterone
timeFrame: Up to Day 4, treatment period 4
measure: Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentration of abiraterone
timeFrame: Up to Day 4, treatment period 4
measure: Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
timeFrame: Up to Day 4, treatment period 4
measure: Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone
timeFrame: Up to Day 4, treatment period 4
measure: First-order rate constant associated with the terminal portion of the curve of abiraterone
timeFrame: Up to Day 4, treatment period 4
measure: Time to last quantifiable plasma concentration of abiraterone
timeFrame: Up to Day 4, treatment period 4
measure: Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone
timeFrame: Up to Day 4, treatment period 4
measure: The number of participants affected by an adverse event
timeFrame: Up to the end of the study (4 days after final dose of study drug) or early withdrawal
Other outcomes:
Locations:
city: Cypress
country: United States
state: California
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Inoue K, Shishido A, Vaccaro N, Jiao J, Stieltjes H, Bernard A, Yu M, Chien C. Pharmacokinetics of abiraterone in healthy Japanese men: dose-proportionality and effect of food timing. Cancer Chemother Pharmacol. 2015 Jan;75(1):49-58. doi: 10.1007/s00280-014-2616-4. Epub 2014 Oct 25.