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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 (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01575587
First received: January 19, 2012
Last updated: January 9, 2014
Last verified: January 2014

January 19, 2012
January 9, 2014
January 2012
May 2012   (final data collection date for primary outcome measure)
Changes in mean plasma concentrations of abiraterone [ Time Frame: Up to Day 4, treatment period 4 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01575587 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Pharmacology
  • Drug: Abiraterone: Treatment A
    1000 mg abiraterone acetate administered in the fasting state
  • Drug: Abiraterone: Treatment B
    Standardized meal administered 1 hour after the 1000 mg abiraterone acetate dose
  • Drug: Abiraterone: Treatment C
    Standardized meal administered 2 hours before the 1000 mg abiraterone acetate dose
  • Drug: Abiraterone: Treatment D
    Standardized meal administered 2 hours before and 2 hours after the 1000 mg abiraterone acetate dose
  • Experimental: Treatment A
    Intervention: Drug: Abiraterone: Treatment A
  • Experimental: Treatment B
    Intervention: Drug: Abiraterone: Treatment B
  • Experimental: Treatment C
    Intervention: Drug: Abiraterone: Treatment C
  • Experimental: Treatment D
    Intervention: Drug: Abiraterone: Treatment D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
May 2012
May 2012   (final data collection date for primary outcome measure)

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.
Male
25 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01575587
CR100737, 212082PCR1005
No
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP