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

NCT01678573 | Completed Phase 1 DMC

• 2 other identifiers: CR100668ABI-PRO-1016
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy; Pharmacokinetics; Abiraterone acetate; Abiraterone; JNJ-212082; Zytiga; Chinese; Fasted

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Number of participants with adverse events

  Up to 42 days

Study Arms (3)

Sequence 1: abiraterone acetate

EXPERIMENTAL

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; Drug: Treatment B: abiraterone acetate; Drug: Treatment C: abiraterone acetate

Sequence 2: abiraterone acetate

EXPERIMENTAL

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; Drug: Treatment B: abiraterone acetate; Drug: Treatment C: abiraterone acetate

Sequence 3: abiraterone acetate

EXPERIMENTAL

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; Drug: Treatment B: abiraterone acetate; Drug: Treatment C: abiraterone acetate

Interventions

Treatment A: abiraterone acetate DRUG

250 mg/day tablet administered orally on Day 1 of each treatment period.

Also known as: ZYTIGA

Sequence 1: abiraterone acetate; Sequence 2: abiraterone acetate; Sequence 3: abiraterone acetate

Treatment B: abiraterone acetate DRUG

500 mg/day tablets administered orally on Day 1 of each treatment period.

Also known as: ZYTIGA

Sequence 1: abiraterone acetate; Sequence 2: abiraterone acetate; Sequence 3: abiraterone acetate

Treatment C: abiraterone acetate DRUG

1000 mg/day tablets administered orally on Day 1 of each treatment period.

Also known as: ZYTIGA

Sequence 1: abiraterone acetate; Sequence 2: abiraterone acetate; Sequence 3: abiraterone acetate

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Beijing, China

Location

MeSH Terms

Interventions

Abiraterone Acetate

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 5, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 6, 2013

Record last verified: 2013-09

Locations

CN (1)