Comparative Formulation Study of Vabicaserin

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00928551
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

This study will compare two different formulations of vabicaserin.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: vabicaserin	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-Label, Single-Dose, 3-Period Crossover, Comparative Study of a Modified Formulation of Vabicaserin (SCA-136) Versus the Reference Formulation in Healthy Subjects
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: vabicaserin

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic parameters including plasma concentrations, Cmax, and AUC. [2 months]

Secondary Outcome Measures

1. Safety assessment as measured by evaluating any reported adverse events, scheduled physical examinations, vital sign measurements, ECGs, and clinical laboratory results. [2 months]

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after investigational product administration.

• Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion Criteria:

• Use of any investigational or prescription drug within 30 days before investigation product administration.

• Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1.

• Use of any over-the-counter drugs, including herbal supplements within 72 hours before study day 1.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Brighton	Massachusetts	United States	2135

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.

• ClinicalTrials.gov Identifier: NCT00928551
• Other Study ID Numbers: 3153B3-1128
• First Posted: Jun 26, 2009
• Last Update Posted: Sep 11, 2009
• Last Verified: Sep 1, 2009

Study Results

No Results Posted as of Sep 11, 2009