Clinical trial NCT01588782: A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Abiraterone Following Administration of Abiraterone Acetate Tablets in Healthy Adult Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Pharmacology
Pharmacokinetics
Pharmacodynamics
Drug-drug interactions
CYP3A4
Abiraterone acetate
JNJ-589485
JNJ-212082
Ketoconazole
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-05-01
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean plasma concentrations of abiraterone
timeFrame: Up to Day 17
measure: Mean plasma concentrations of ketoconazole
timeFrame: Up to Day 14
measure: Maximum plasma concentrations of abiraterone
timeFrame: Up to Day 17
measure: Time to reach the maximum plasma concentration of abiraterone
timeFrame: Up to Day 17
measure: Area under the plasma concentration-time curve from time 0 to time to the last quantifiable concentration of abiraterone
timeFrame: Up to Day 17
measure: Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
timeFrame: Up to Day 17
measure: Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone
timeFrame: Up to Day 17
measure: First-order rate constant associated with the terminal portion of the curve of abiraterone
timeFrame: Up to Day 17
measure: Time to last quantifiable plasma concentration of abiraterone
timeFrame: Up to Day 17
measure: Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone
timeFrame: Up to Day 17
Secondary outcomes:
measure: The number of participants affected by an adverse event
timeFrame: Up to end of study or early withdrawal
Other outcomes:
Locations:
city: Merksem
country: Belgium
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: