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Study Comparing Bioavailability of Oral Formulations of Vabicaserin

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.
 
ClinicalTrials.gov Identifier: NCT00541996
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : December 5, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
The purpose of this study is to determine the absorption rate of four oral formulations of vabicaserin.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: vabicaserin Phase 1

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : August 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine





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

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


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.


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

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.

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): NCT00541996


Locations
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United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
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ClinicalTrials.gov Identifier: NCT00541996    
Other Study ID Numbers: 3153A1-1116
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: December 5, 2007
Last Verified: December 2007
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders