Study Comparing Bioavailability of Oral Formulations of Vabicaserin
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00541996
Collaborator
(none)
1
2
Study Details
Study Description
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 |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
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
:
Aug 1, 2007
Actual Study Completion Date
:
Oct 1, 2007
Outcome Measures
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. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes 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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Philadelphia | Pennsylvania | United States | 19148 |
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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00541996
Other Study ID Numbers:
- 3153A1-1116
First Posted:
Oct 10, 2007
Last Update Posted:
Dec 5, 2007
Last Verified:
Dec 1, 2007
Additional relevant MeSH terms: