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Study Evaluating the Tolerability of Bifeprunox in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00581451
First Posted: December 27, 2007
Last Update Posted: July 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
Safety and tolerability study in healthy volunteers

Condition Intervention Phase
Healthy Drug: bifeprunox Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 28 days ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Healthy male 18-50 years
  • Nonlactating female 18-50 years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00581451     History of Changes
Other Study ID Numbers: 3168A2-1005
First Submitted: December 21, 2007
First Posted: December 27, 2007
Last Update Posted: July 10, 2009
Last Verified: July 2009