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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014