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Study Evaluating IMA-638 in Healthy Japanese

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00340327
First Posted: June 21, 2006
Last Update Posted: December 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Diagnostic
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 is now a wholly owned subsidiary of Pfizer:

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • First generation healthy Japanese men and women of non-childbearing potential.
  Contacts and Locations
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): NCT00340327


Locations
United States, California
Glendale, California, United States, 91206
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

ClinicalTrials.gov Identifier: NCT00340327     History of Changes
Other Study ID Numbers: 3174K1-101
First Submitted: June 16, 2006
First Posted: June 21, 2006
Last Update Posted: December 5, 2007
Last Verified: December 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
healthy subjects