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Study to Evaluate Multiple Doses of ERB-041 in Healthy, Female Japanese Subjects

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: February 9, 2007
Last updated: July 8, 2009
Last verified: July 2009
The primary objective is evaluate the safety, tolerability, and pharmacokinetics of multiple doses of ERB-041, an investigational drug, in healthy, female Japanese subjects.

Condition Intervention Phase
Drug: ERB-041
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: An Ascending Multiple Dose Study of the Safety, Tolerability and Pharmacokinetics of ERB-041 Administered Orally to Healthy, Female Japanese Subjects

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • safety, pharmacokinetics

Estimated Enrollment: 24
Study Start Date: August 2006
Estimated Study Completion Date: October 2006

Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy as determined by the investigator on the basis of medical history and screening evaluations.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00434187

Kan-nondai, Tsukuba-shi, Ibaraki, Japan, 305-0856
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information Identifier: NCT00434187     History of Changes
Other Study ID Numbers: 3142A2-115 
Study First Received: February 9, 2007
Last Updated: July 8, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
healthy processed this record on December 09, 2016