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

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ClinicalTrials.gov Identifier: NCT01678573
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : September 6, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Treatment A: abiraterone acetate Drug: Treatment B: abiraterone acetate Drug: Treatment C: abiraterone acetate Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Dose, Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Pharmacokinetics of Abiraterone in Chinese Healthy Male Subjects
Study Start Date : July 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

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Arms and Interventions
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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 Name: ZYTIGA

Drug: Treatment B: abiraterone acetate
500 mg/day tablets administered orally on Day 1 of each treatment period.
Other Name: ZYTIGA

Drug: Treatment C: abiraterone acetate
1000 mg/day tablets administered orally on Day 1 of each treatment period.
Other Name: 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 Name: ZYTIGA

Drug: Treatment B: abiraterone acetate
500 mg/day tablets administered orally on Day 1 of each treatment period.
Other Name: ZYTIGA

Drug: Treatment C: abiraterone acetate
1000 mg/day tablets administered orally on Day 1 of each treatment period.
Other Name: 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 Name: ZYTIGA

Drug: Treatment B: abiraterone acetate
500 mg/day tablets administered orally on Day 1 of each treatment period.
Other Name: ZYTIGA

Drug: Treatment C: abiraterone acetate
1000 mg/day tablets administered orally on Day 1 of each treatment period.
Other Name: ZYTIGA


Outcome Measures
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Primary Outcome Measures :
  1. Maximum observed plasma concentration of abiraterone [ Time Frame: Pre-dose and up to 96 hours post-dose each treatment period ]
  2. Time to reach the maximum observed plasma concentration of abiraterone [ Time Frame: Pre-dose and up to 96 hours post-dose each treatment period ]
  3. Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration of abiraterone [ Time Frame: Pre-dose and up to 96 hours post-dose each treatment period ]
  4. Area under the plasma concentration-time curve extrapolated to infinite time of abiraterone [ Time Frame: Pre-dose and up to 96 hours post-dose each treatment period ]
  5. Apparent terminal elimination rate constant of abiraterone [ Time Frame: Pre-dose and up to 96 hours post-dose each treatment period ]
  6. Apparent terminal elimination half-life of abiraterone [ Time Frame: Pre-dose and up to 96 hours post-dose each treatment period ]

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Up to 42 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678573


Locations
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China
Beijing, China
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01678573    
Other Study ID Numbers: CR100668
ABI-PRO-1016 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: September 6, 2013
Last Verified: September 2013
Keywords provided by Janssen Research & Development, LLC:
Healthy
Pharmacokinetics
Abiraterone acetate
Abiraterone
 JNJ-212082
Zytiga
Chinese
Fasted
Additional relevant MeSH terms:
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Abiraterone Acetate
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors