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

Healthy Volunteers Clinical Trial

Official title:

An Open-Label Drug-Drug Interaction Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone (JNJ-589485) Following Administration of Abiraterone Acetate (JNJ-212082) Tablets in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588782
• Other study ID #: CR100650
• Secondary ID: 212082PCR1002
• Status: Completed
• Phase: Phase 1
• First received: January 9, 2012
• Last updated: November 23, 2012
• Start date: January 2012
• Est. completion date: February 2012

Study information

• Verified date: November 2012
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Period 1: Abiraterone
1000 mg abiraterone acetate tablet administered orally on Day 1
• Period 2: Abiraterone/Ketoconazole
400 mg ketoconazole tablets administered orally on Days 11 to 16
• Period 2: Abiraterone/Ketoconazole
1000 mg abiraterone acetate tablet administered orally on Day 14

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean plasma concentrations of abiraterone		Up to Day 17	No
Primary	Mean plasma concentrations of ketoconazole		Up to Day 14	No
Primary	Maximum plasma concentrations of abiraterone		Up to Day 17	No
Primary	Time to reach the maximum plasma concentration of abiraterone		Up to Day 17	No
Primary	Area under the plasma concentration-time curve from time 0 to time to the last quantifiable concentration of abiraterone		Up to Day 17	No
Primary	Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone		Up to Day 17	No
Primary	Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone		Up to Day 17	No
Primary	First-order rate constant associated with the terminal portion of the curve of abiraterone		Up to Day 17	No
Primary	Time to last quantifiable plasma concentration of abiraterone		Up to Day 17	No
Primary	Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone		Up to Day 17	No
Secondary	The number of participants affected by an adverse event		Up to end of study or early withdrawal	Yes