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Trial record 1 of 1 for:    NCT00434785
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A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males

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ClinicalTrials.gov Identifier: NCT00434785
Recruitment Status : Completed
First Posted : February 13, 2007
Last Update Posted : December 5, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE February 9, 2007
First Posted Date  ICMJE February 13, 2007
Last Update Posted Date December 5, 2007
Study Start Date  ICMJE February 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February¬†12,¬†2007)
To assess the safety and PK profile
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00434785 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 in Healthy Japanese Males
Official Title  ICMJE An Ascending, Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of AGG-523 Administered Orally to Healthy Male Japanese Subjects.
Brief Summary To assess the safety and tolerability of ascending, multiple oral doses of AGG-523 in healthy Japanese 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: AGG-523
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 Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men aged 20 to 40 years, inclusive, at screening; sexually active men must agree to use a medically acceptable form of contraception during the study and continue for 12 weeks after test article administration.
  • Body mass index (BMI) in the range of 17.6 to 26.4 Kgm2, and body weight >45 kg.
  • 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 40 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 NCT00434785
Other Study ID Numbers  ICMJE 3189A1-105
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 Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

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