NCT01798628

Brief Summary

The purpose of this study is to determine the effect of food on the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate 1000 mg when administered as a single dose in healthy male volunteers.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_1 healthy-volunteers

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

September 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
Last Updated

February 26, 2013

Status Verified

February 1, 2013

Enrollment Period

1 month

First QC Date

October 22, 2012

Last Update Submit

February 22, 2013

Conditions

Healthy Volunteers

Keywords

Healthy volunteersAbiraterone acetatePharmacokinetics

Outcome Measures

Primary Outcomes (6)

  • Maximum observed concentration of abiraterone

    Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose

  • Time to maximum concentration of abiraterone

    Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose

  • Area under the concentration-time curve from time 0 to the last measurable concentration of abiraterone

    Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose

  • Area under the concentration-time curve extrapolated to infinity of abiraterone

    Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose

  • Apparent plasma terminal elimination rate constant of abiraterone

    Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose

  • Apparent terminal elimination half-life of abiraterone

    Within 1 hour prior to dose and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 96 hours post-dose

Secondary Outcomes (1)

  • Number of participants affected by an adverse event

    Up to Day 21

Study Arms (6)

Sequence ABC

EXPERIMENTAL
Drug: Treatment A: abiraterone acetateDrug: Treatment B: abiraterone acetateDrug: Treatment C: abiraterone acetate

Sequence ACB

EXPERIMENTAL
Drug: Treatment A: abiraterone acetateDrug: Treatment B: abiraterone acetateDrug: Treatment C: abiraterone acetate

Sequence BAC

EXPERIMENTAL
Drug: Treatment A: abiraterone acetateDrug: Treatment B: abiraterone acetateDrug: Treatment C: abiraterone acetate

Sequence BCA

EXPERIMENTAL
Drug: Treatment A: abiraterone acetateDrug: Treatment B: abiraterone acetateDrug: Treatment C: abiraterone acetate

Sequence CAB

EXPERIMENTAL
Drug: Treatment A: abiraterone acetateDrug: Treatment B: abiraterone acetateDrug: Treatment C: abiraterone acetate

Sequence CBA

EXPERIMENTAL
Drug: Treatment A: abiraterone acetateDrug: Treatment B: abiraterone acetateDrug: Treatment C: abiraterone acetate

Interventions

Treatment A: abiraterone acetateDRUG

1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal

Sequence ABCSequence ACBSequence BACSequence BCASequence CABSequence CBA
Treatment B: abiraterone acetateDRUG

1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal

Sequence ABCSequence ACBSequence BACSequence BCASequence CABSequence CBA
Treatment C: abiraterone acetateDRUG

1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state

Sequence ABCSequence ACBSequence BACSequence BCASequence CABSequence CBA

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • In good general health as determined by no clinically significant findings on medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory measurements
  • Body mass index within 18 kg/m2 to 32 kg/m2, inclusive
  • Non-tobacco users
  • Clinical laboratory values within protocol-defined parameters
  • Negative hepatitis panel (including hepatitis B surface antigen \[HBsAg\] and hepatitis C virus antibody \[anti-HCV\]),and negative human immunodeficiency virus (HIV) antibody screens
  • Negative test for selected drugs of abuse
  • Agrees to protocol-defined use of effective contraception

You may not qualify if:

  • Significant history or manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological or psychiatric disorder, as determined by the Principal Investigator
  • History or presence of an abnormal electrocardiogram
  • History of stomach or intestinal surgery resection that would potentially alter absorption and/or excretion of orally administered drugs
  • Screening serum total testosterone of \<200 ng/dL
  • History of hypersensitivity reaction to the study drug, related compounds or excipients used in the formulation
  • Receipt of an investigational drug within 5 half-lives or 30 days prior to Day -1, whichever is longer
  • Abnormal diet during the 30 days prior to Day 1
  • Donation of blood or significant loss of blood within 56 days or plasma within 14 days prior to Day -1
  • Planned donation of blood or plasma from Screening through Study Completion, Day 21
  • Receipt of blood products within 2 months prior to Day 1
  • History of protocol-defined alcohol abuse
  • Known or suspected use of illicit drugs within the last year
  • Use of any medication on a chronic basis
  • Use of any prescription medications/products or over-the-counter non-prescription preparations within 5 half-lives or 7 days prior to Day -1 unless deemed acceptable by the Sponsor
  • Consumption of alcohol-containing foods or beverages within 24 hours prior to the first Check-in (Day -1)
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Cougar Biotechnology, Inc. Clinical Trial

    Cougar Biotechnology, Inc.

    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

October 22, 2012

First Posted

February 26, 2013

Study Start

September 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

February 26, 2013

Record last verified: 2013-02