Study Evaluating the Tolerability of Bifeprunox in Healthy Subjects

This study has been completed.

First Received on December 21, 2007. Last Updated on July 8, 2009 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00581451

Purpose

Safety and tolerability study in healthy volunteers

Condition	Intervention	Phase
Healthy	Drug: bifeprunox	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title:	A 3-Part, Randomized, Multiple-Dose, Sequential Design Study of Bifeprunox in Healthy Subjects in Order to Establish a Titration Regimen With an Improved Tolerability Profile

Resource links provided by NLM:

Drug Information available for: Bifeprunox Bifeprunox mesylate

U.S. FDA Resources

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

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	144
Study Start Date:	October 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A bifeprunox 25 day	Drug: bifeprunox oral tablet once daily
Experimental: B bifeprunox 14 day	Drug: bifeprunox oral tablet once daily
Experimental: C bifeprunox 14 day	Drug: bifeprunox oral tablet once daily
Experimental: D bifeprunox 9 day	Drug: bifeprunox oral tablet once daily

Eligibility

Criteria

Inclusion criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581451

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

No publications provided

Responsible Party:	Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier:	NCT00581451 History of Changes
Other Study ID Numbers:	3168A2-1005
Study First Received:	December 21, 2007
Last Updated:	July 8, 2009
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on February 12, 2012