A Study to Evaluate the Pharmacokinetics of Abiraterone in Healthy Chinese Male Participants
Information source: Janssen Research & Development, LLC
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Treatment A: abiraterone acetate (Drug); Treatment B: abiraterone acetate (Drug); Treatment C: abiraterone acetate (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Janssen Research & Development, LLC Official(s) and/or principal investigator(s): Janssen Research & Development, LLC Clinical Trial, Study Director, Affiliation: Janssen Research & Development, LLC
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.
Clinical Details
Official title: A Single-Dose, Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Pharmacokinetics of Abiraterone in Chinese Healthy Male Subjects
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Maximum observed plasma concentration of abirateroneTime to reach the maximum observed plasma concentration of abiraterone Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of abiraterone Area under the plasma concentration-time curve extrapolated to infinite time of abiraterone Apparent terminal elimination rate constant of abiraterone Apparent terminal elimination half-life of abiraterone
Secondary outcome: Number of participants with adverse events
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
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Male.
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)
Locations and Contacts
Beijing, China
Additional Information
Starting date: July 2012
Last updated: September 5, 2013
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