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

Pharmacology Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575587
• Other study ID #: CR100737
• Secondary ID: 212082PCR1005
• Status: Completed
• Phase: Phase 1
• First received: January 19, 2012
• Last updated: January 9, 2014
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: January 2014
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharmacology

Intervention

Drug:
• Abiraterone: Treatment A
1000 mg abiraterone acetate administered in the fasting state
• Abiraterone: Treatment B
Standardized meal administered 1 hour after the 1000 mg abiraterone acetate dose
• Abiraterone: Treatment C
Standardized meal administered 2 hours before the 1000 mg abiraterone acetate dose
• Abiraterone: Treatment D
Standardized meal administered 2 hours before and 2 hours after the 1000 mg abiraterone acetate dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in mean plasma concentrations of abiraterone		Up to Day 4, treatment period 4	No
Secondary	Mean plasma concentrations of abiraterone		Up to Day 4, treatment period 4	No
Secondary	Maximum plasma concentration of abiraterone		Up to Day 4, treatment period 4	No
Secondary	Time to reach the maximum plasma concentration of abiraterone		Up to Day 4, treatment period 4	No
Secondary	Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentration of abiraterone		Up to Day 4, treatment period 4	No
Secondary	Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone		Up to Day 4, treatment period 4	No
Secondary	Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone		Up to Day 4, treatment period 4	No
Secondary	First-order rate constant associated with the terminal portion of the curve of abiraterone		Up to Day 4, treatment period 4	No
Secondary	Time to last quantifiable plasma concentration of abiraterone		Up to Day 4, treatment period 4	No
Secondary	Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone		Up to Day 4, treatment period 4	No
Secondary	The number of participants affected by an adverse event		Up to the end of the study (4 days after final dose of study drug) or early withdrawal	Yes