NCT01588782

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics, safety, and potential for drug-drug interactions when a strong inhibitor of CYP3A4 (ie, ketoconazole) is co-administered with abiraterone acetate in healthy adult men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1 healthy-volunteers

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
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 1, 2012

Completed
Last Updated

November 27, 2012

Status Verified

November 1, 2012

Enrollment Period

1 month

First QC Date

January 9, 2012

Last Update Submit

November 23, 2012

Conditions

Healthy Volunteers

Keywords

Healthy volunteersPharmacologyPharmacokineticsPharmacodynamicsDrug-drug interactionsCYP3A4Abiraterone acetateJNJ-589485JNJ-212082Ketoconazole

Outcome Measures

Primary Outcomes (10)

  • Mean plasma concentrations of abiraterone

    Up to Day 17

  • Mean plasma concentrations of ketoconazole

    Up to Day 14

  • Maximum plasma concentrations of abiraterone

    Up to Day 17

  • Time to reach the maximum plasma concentration of abiraterone

    Up to Day 17

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

    Up to Day 17

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

    Up to Day 17

  • Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone

    Up to Day 17

  • First-order rate constant associated with the terminal portion of the curve of abiraterone

    Up to Day 17

  • Time to last quantifiable plasma concentration of abiraterone

    Up to Day 17

  • Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone

    Up to Day 17

Secondary Outcomes (1)

  • The number of participants affected by an adverse event

    Up to end of study or early withdrawal

Study Arms (1)

Abiraterone acetate

EXPERIMENTAL

All individuals will receive study treatment in the same sequence. Period 1 (Days 1 to 4) consists of a single oral dose of 1000 mg abiraterone acetate tablets on Day 1 only. Period 2 (Days 11 to 17) consists of a daily oral dose of 400 mg ketoconazole tablets on Days 11 to 16 and administration of a single dose of 1000 mg abiraterone acetate on Day 14.

Drug: Period 1: AbirateroneDrug: Period 2: Abiraterone/Ketoconazole

Interventions

Period 1: AbirateroneDRUG

1000 mg abiraterone acetate tablet administered orally on Day 1

Abiraterone acetate
Period 2: Abiraterone/KetoconazoleDRUG

400 mg ketoconazole tablets administered orally on Days 11 to 16

Abiraterone acetate

Eligibility Criteria

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

You may qualify if:

  • \- Body mass index (BMI) between 18 and 30 kg/m2, inclusive

You may not qualify if:

  • \- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Merksem, Belgium

Location

MeSH Terms

Interventions

Ketoconazole

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Janssen Research & Development, LLC Clinical Trial

    Janssen Research & Development, LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2012

First Posted

May 1, 2012

Study Start

January 1, 2012

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

November 27, 2012

Record last verified: 2012-11

Locations

BE(1)