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

This study is ongoing, but not recruiting participants.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00434187

Purpose

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
Healthy	Drug: ERB-041	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study
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:

Primary Outcome Measures:

safety, pharmacokinetics

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

Eligibility

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

Criteria

Inclusion Criteria:

Healthy as determined by the investigator on the basis of medical history and screening evaluations.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434187

Locations

Japan, Ibaraki

Kan-nondai, Tsukuba-shi, Ibaraki, Japan, 305-0856

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3142A2-115
Study First Received:	February 9, 2007
Last Updated:	February 12, 2007
ClinicalTrials.gov Identifier:	NCT00434187
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Wyeth:

healthy

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 13, 2009