Comparative Formulation Study of Vabicaserin

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: vabicaserin

• Registration Number: NCT00928551
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

This study will compare two different formulations of vabicaserin.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-24
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Status Verified: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Last Update Submitted: 2009-09-10
• Last Update Posted: 2009-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	vabicaserin	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters including plasma concentrations, Cmax, and AUC.	2 months

Secondary Outcome Measures

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