Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Study Evaluating IMA-638 in Healthy Japanese
This study has been completed.
Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00340327
  Purpose

The purpose of this study is to evaluate the safety and drug levels for single, ascending doses of IMA-638 in healthy Japanese subjects.


Condition Intervention Phase
Healthy
Drug: IMA-638
Phase I

U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
Official Title: An Ascending Single Dose Study of the Safety and Pharmacokinetics of IMA-638 Administered to Healthy Japanese Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:
  • Safety will be measured by evaluating physical examinations, vital signs, electrocardiograms (ECGs), and clinical laboratory test results.

Secondary Outcome Measures:
  • Drug levels and associated biomarkers will be evaluated.

Study Start Date: June 2006
Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • First generation healthy Japanese men and women of non-childbearing potential.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00340327

Locations
United States, California
Glendale, California, United States, 91206
Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
  More Information

Study ID Numbers: 3174K1-101
Study First Received: June 16, 2006
Last Updated: December 3, 2007
ClinicalTrials.gov Identifier: NCT00340327  
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth:
healthy subjects

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on January 16, 2009