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A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone Following Administration of Abiraterone Acetate Tablets in Healthy Adult Men

NCT ID: NCT01588782

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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This is a non-randomized (individuals will not be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), 2-period, sequential-design, drug-drug interaction study of abiraterone acetate and ketoconazole in approximately 20 healthy adult men. This study will consist of a screening period followed by an open-label treatment phase consisting of 2 treatment periods. Successive drug administration will be separated by a washout period of at least 10 days. 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. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected at each treatment period as detailed in the protocol. Safety will be monitored continuously from the time of informed consent signing until the end of the study.

Conditions

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Healthy Volunteers

Keywords

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Healthy volunteers Pharmacology Pharmacokinetics Pharmacodynamics Drug-drug interactions CYP3A4 Abiraterone acetate JNJ-589485 JNJ-212082 Ketoconazole

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Abiraterone acetate

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.

Group Type EXPERIMENTAL

Period 1: Abiraterone

Intervention Type DRUG

1000 mg abiraterone acetate tablet administered orally on Day 1

Period 2: Abiraterone/Ketoconazole

Intervention Type DRUG

400 mg ketoconazole tablets administered orally on Days 11 to 16

Period 2: Abiraterone/Ketoconazole

Intervention Type DRUG

1000 mg abiraterone acetate tablet administered orally on Day 14

Interventions

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Period 1: Abiraterone

1000 mg abiraterone acetate tablet administered orally on Day 1

Intervention Type DRUG

Period 2: Abiraterone/Ketoconazole

400 mg ketoconazole tablets administered orally on Days 11 to 16

Intervention Type DRUG

Period 2: Abiraterone/Ketoconazole

1000 mg abiraterone acetate tablet administered orally on Day 14

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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Merksem, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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212082PCR1002

Identifier Type: OTHER

Identifier Source: secondary_id

CR100650

Identifier Type: -

Identifier Source: org_study_id