Study Evaluating the Pharmacokinetics of HCV-796 in Healthy Japanese Men

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NCT00385190

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Study Location
Minato-ku, Tokyo, 108-8642, Japan
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-45 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Pharmacokinetics of HCV-796 in Healthy Japanese Men
Official Title  ICMJE An Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of Study Drug Administred Orally to Healthy Japanese Male Subjects
Brief Summary The purpose of the study is to assess the safety and tolerability of ascending multiple oral doses of HCV-796 in healthy Japanese male subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: HCV-796
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 5, 2006)		24
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00385190
Other Study ID Numbers  ICMJE 3173A1-108
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP