Study Comparing Bioavailability of Oral Formulations of Vabicaserin

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: October 5, 2007
Last updated: December 3, 2007
Last verified: December 2007
The purpose of this study is to determine the absorption rate of four oral formulations of vabicaserin.

Condition Intervention Phase
Drug: vabicaserin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Randomized, Open-Label, Single-Dose, 4-Period Crossover, Comparative Bioavailability Study of 3 Sustained- Release Formulations and an Immediate- Release Formulation of Vabicaserin (SCA-136) in Healthy Subjects

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

Primary Outcome Measures:
  • Assess the bioavailability of four oral formulations of vabicaserin.

Secondary Outcome Measures:
  • Obtain additional safety and tolerability data for vabicaserin in healthy male subjects.

Study Start Date: August 2007
Study Completion Date: October 2007

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

Inclusion Criteria:

  • Healthy men aged 18-50 years.

Exclusion Criteria:

  • Any significant disease state.
  • History of drug or alcohol abuse within 1 year.
  • Abnormal liver function tests.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00541996

United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information Identifier: NCT00541996     History of Changes
Other Study ID Numbers: 3153A1-1116 
Study First Received: October 5, 2007
Last Updated: December 3, 2007
Health Authority: United States: Food and Drug Administration processed this record on May 02, 2016