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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 abiraterone

Time 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

Page last updated: August 23, 2015

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