A Study to Evaluate the Pharmacokinetics of Abiraterone in Healthy Chinese Male Participants

A Single-Dose, Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Pharmacokinetics of Abiraterone in Chinese Healthy Male Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Treatment A: abiraterone acetate; Drug: Treatment B: abiraterone acetate; Drug: Treatment C: abiraterone acetate

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sequence 1: abiraterone acetate; Randomly assigned participants in Sequence 1 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 the randomized schedule "ABC" under fasted conditions.	Drug: Treatment A: abiraterone acetate; 250 mg/day tablet administered orally on Day 1 of each treatment period.; Other Names: ZYTIGA; Drug: Treatment B: abiraterone acetate; 500 mg/day tablets administered orally on Day 1 of each treatment period.; Other Names: ZYTIGA; Drug: Treatment C: abiraterone acetate; 1000 mg/day tablets administered orally on Day 1 of each treatment period.; Other Names: ZYTIGA
EXPERIMENTAL: Sequence 2: abiraterone acetate; Randomly assigned participants in Sequence 2 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 the randomized schedule "BAC" under fasted conditions.	Drug: Treatment A: abiraterone acetate; 250 mg/day tablet administered orally on Day 1 of each treatment period.; Other Names: ZYTIGA; Drug: Treatment B: abiraterone acetate; 500 mg/day tablets administered orally on Day 1 of each treatment period.; Other Names: ZYTIGA; Drug: Treatment C: abiraterone acetate; 1000 mg/day tablets administered orally on Day 1 of each treatment period.; Other Names: ZYTIGA
EXPERIMENTAL: Sequence 3: abiraterone acetate; Randomly assigned participants in Sequence 3 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 the randomized schedule "CBA" under fasted conditions.	Drug: Treatment A: abiraterone acetate; 250 mg/day tablet administered orally on Day 1 of each treatment period.; Other Names: ZYTIGA; Drug: Treatment B: abiraterone acetate; 500 mg/day tablets administered orally on Day 1 of each treatment period.; Other Names: ZYTIGA; Drug: Treatment C: abiraterone acetate; 1000 mg/day tablets administered orally on Day 1 of each treatment period.; Other Names: ZYTIGA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration of abiraterone	Pre-dose and up to 96 hours post-dose each treatment period
Time to reach the maximum observed plasma concentration of abiraterone	Pre-dose and up to 96 hours post-dose each treatment period
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of abiraterone	Pre-dose and up to 96 hours post-dose each treatment period
Area under the plasma concentration-time curve extrapolated to infinite time of abiraterone	Pre-dose and up to 96 hours post-dose each treatment period
Apparent terminal elimination rate constant of abiraterone	Pre-dose and up to 96 hours post-dose each treatment period
Apparent terminal elimination half-life of abiraterone	Pre-dose and up to 96 hours post-dose each treatment period

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	Up to 42 days

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: August 31, 2012
• First Submitted That Met QC Criteria: August 31, 2012
• First Posted (ESTIMATE): September 5, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): September 6, 2013
• Last Update Submitted That Met QC Criteria: September 5, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Chinese; Healthy; Pharmacokinetics; Abiraterone acetate; Abiraterone; Zytiga; JNJ-212082; Fasted
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Abiraterone Acetate
• Other Study ID Numbers: CR100668; ABI-PRO-1016 (OTHER: Janssen Research & Development, LLC)