Study Evaluating the Safety and Tolerability of NSA-789

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: NSA-789; Drug: placebo

• Registration Number: NCT00633048
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

This is the first time that NSA-789, a new compound being developed for schizophrenia, will be given to humans. Each healthy subject will receive a single dose, except for 8 subjects who will receive 2 doses-- one dose under fasting conditions and one dose after eating food.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-08
• Study Start: 2008-03
• Study First Submitted QC: 2008-03-10
• Study First Posted: 2008-03-11
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-16
• Last Update Posted: 2009-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSA-789	NSA-789	active drug
placebo	placebo	placebo

Primary Outcome Measures

Name	Time	Method
Safety and tolerability from reported adverse events, scheduled physical examinations, vital signs, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results	3 months

Secondary Outcome Measures

Name	Time	Method
pharmacokinetics	3 months