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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Period 2: Abiraterone/Ketoconazole; Drug: Period 1: Abiraterone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01588782

212082PCR1002 (Other Identifier)

CR100650

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Abiraterone acetate

Experimental group

Description:

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.

Treatment:

Drug: Period 2: Abiraterone/Ketoconazole

Drug: Period 1: Abiraterone

Drug: Period 2: Abiraterone/Ketoconazole