Study Evaluating the Tolerability of Bifeprunox in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00581451
First received: December 21, 2007
Last updated: July 8, 2009
Last verified: July 2009
  Purpose

Safety and tolerability study in healthy volunteers


Condition Intervention Phase
Healthy
Drug: bifeprunox
Phase 1

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

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

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
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

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 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 April 14, 2014