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Study Evaluating the Tolerability of Bifeprunox in Healthy Subjects
This study has been completed.
First Received: December 21, 2007   Last Updated: July 8, 2009   History of Changes
Sponsor: 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

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

Resource links provided by NLM:


Further study details as provided by Wyeth:

Primary Outcome Measures:
  • Tolerability [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

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
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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy male 18-50 years
  • Nonlactating female 18-50 years
  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

No publications provided

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

ClinicalTrials.gov processed this record on November 30, 2009