Clinical trial NCT01678573: A Study to Evaluate the Pharmacokinetics of Abiraterone in Healthy Chinese Male Participants
Official title: A Single-Dose, Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Pharmacokinetics of Abiraterone in Chinese Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy
Pharmacokinetics
Abiraterone acetate
Abiraterone
JNJ-212082
Zytiga
Chinese
Fasted
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-09-05
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate after oral administration of abiraterone acetate at different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under fasted conditions.

Detailed description: This is an open-label (all people know the identity of the intervention), randomized (the treatment sequence is assigned by chance), 3-way crossover study (method used to switch participants from one dose level to another in a clinical study) of single doses of abiraterone acetate in healthy Chinese male participants. The study consists of 3 phases: screening, open-label treatment, and follow up phases. After screening, randomly assigned participants will receive different dose levels of abiraterone acetate (Treatment A = 250 mg; Treatment B = 500 mg; and Treatment C = 1000 mg) on Day 1 in each of the 3 treatment periods according to a randomized schedule under fasted conditions (Sequence 1 = ABC; Sequence 2 = BAC; and Sequence 3 = CBA). Each treatment period will be separated by a washout period (period when participant is not receiving any study medication) of at least 7 days. In the follow-up phase, study-related adverse events will be monitored by the investigator. Serial blood samples for pharmacokinetic analysis will be collected and safety will be monitored throughout the study. The total study duration will be approximately 42 days.

Eligibility criteria: Inclusion Criteria:

* Body mass index within 18 to 27 kg/m2 (inclusive) and body weight above 50 kg at screening
* Protocol-defined laboratory and electrocardiogram parameters
* Negative test results for selected medications and substances of abuse and negative exhaled carbon monoxide test at check-in day of each period
* Agrees to protocol-defined use of effective contraception
* Willing to be confined at the clinical research facility for time period specified in the protocol

Exclusion Criteria:

* Significant history or current manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
* History of hypersensitivity reaction to the study medication or related compounds or excipients used in the formulation
* Confirmed hepatitis A, B, or C infection or human immunodeficiency virus (HIV) 1 or HIV-2 infection at screening
* Serum testosterone level of \<200 ng/dL
* Use of any tobacco or nicotine-containing products
* Known or suspected use of illicit drugs in the last year
* Protocol contraindicated medications/preparations (prescription and non-prescription)

Primary outcomes:
measure: Maximum observed plasma concentration of abiraterone
timeFrame: Pre-dose and up to 96 hours post-dose each treatment period
measure: Time to reach the maximum observed plasma concentration of abiraterone
timeFrame: Pre-dose and up to 96 hours post-dose each treatment period
measure: Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of abiraterone
timeFrame: Pre-dose and up to 96 hours post-dose each treatment period
measure: Area under the plasma concentration-time curve extrapolated to infinite time of abiraterone
timeFrame: Pre-dose and up to 96 hours post-dose each treatment period
measure: Apparent terminal elimination rate constant of abiraterone
timeFrame: Pre-dose and up to 96 hours post-dose each treatment period
measure: Apparent terminal elimination half-life of abiraterone
timeFrame: Pre-dose and up to 96 hours post-dose each treatment period
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to 42 days
Other outcomes:
Locations:
city: Beijing
country: China
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: