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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
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 October 15, 2008




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