NCT01575587

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

January 19, 2012

Last Update Submit

January 9, 2014

Conditions

Pharmacology

Keywords

PharmacologyPharmacokineticsPharmacodynamicsAbiraterone acetateFood intakeCaucasionJapaneseHealthy

Outcome Measures

Primary Outcomes (1)

  • Changes in mean plasma concentrations of abiraterone

    Up to Day 4, treatment period 4

Secondary Outcomes (10)

  • Mean plasma concentrations of abiraterone

    Up to Day 4, treatment period 4

  • Maximum plasma concentration of abiraterone

    Up to Day 4, treatment period 4

  • Time to reach the maximum plasma concentration of abiraterone

    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

    Up to Day 4, treatment period 4

  • Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone

    Up to Day 4, treatment period 4

  • +5 more secondary outcomes

Study Arms (4)

Treatment A

EXPERIMENTAL
Drug: Abiraterone: Treatment A

Treatment B

EXPERIMENTAL
Drug: Abiraterone: Treatment B

Treatment C

EXPERIMENTAL
Drug: Abiraterone: Treatment C

Treatment D

EXPERIMENTAL
Drug: Abiraterone: Treatment D

Interventions

Abiraterone: Treatment ADRUG

1000 mg abiraterone acetate administered in the fasting state

Treatment A
Abiraterone: Treatment BDRUG

Standardized meal administered 1 hour after the 1000 mg abiraterone acetate dose

Treatment B
Abiraterone: Treatment CDRUG

Standardized meal administered 2 hours before the 1000 mg abiraterone acetate dose

Treatment C
Abiraterone: Treatment DDRUG

Standardized meal administered 2 hours before and 2 hours after the 1000 mg abiraterone acetate dose

Treatment D

Eligibility Criteria

Age25 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Cypress, California, United States

Location

Related Publications (1)

  • 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.

    PMID: 25344090DERIVED

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2012

First Posted

April 11, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

US(1)