Study Evaluating the Tolerability of Bifeprunox in Healthy Subjects - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00581451

Purpose

Safety and Tolerability study in healthy volunteers

Condition	Intervention	Phase
Healthy	Drug: bifeprunox	Phase I

Drug Information available for: Bifeprunox Bifeprunox mesylate

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator), Single Group Assignment, Safety Study
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

Further study details as provided by Wyeth:

Primary Outcome Measures:

Secondary Outcome Measures:

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

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

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3168A2-1005
Study First Received:	December 21, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00581451
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

inpatient ascending dose study to evaluate safety and tolerabi

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 13, 2009