Back to resultsStudy Comparing Bioavailability of Oral Formulations of Vabicaserin
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
vabicaserin
Sponsored by
About this trial
This is an interventional health services research trial for Schizophrenia
Eligibility 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.
Sites / Locations
Outcomes
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.
Full Information
NCT ID
NCT00541996
First Posted
October 5, 2007
Last Updated
December 3, 2007
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00541996
Brief Title
Study Comparing Bioavailability of Oral Formulations of Vabicaserin
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 Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the absorption rate of four oral formulations of vabicaserin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
vabicaserin
Primary Outcome Measure Information:
Title
Assess the bioavailability of four oral formulations of vabicaserin.
Secondary Outcome Measure Information:
Title
Obtain additional safety and tolerability data for vabicaserin in healthy male subjects.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19148
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Comparing Bioavailability of Oral Formulations of Vabicaserin
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