Study Evaluating Multiple Ascending Dose in Schizophrenia Patients

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: SLV-313 SR

• Registration Number: NCT00620568
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

This is a randomized, inpatient, ascending multiple dose study to assess safety and tolerability of SLV-313 SR tablets administered orally to subjects with schizophrenia and schizoaffective disorder.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-08
• Study First Submitted QC: 2008-02-08
• Study First Posted: 2008-02-21
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-03
• Last Update Posted: 2009-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Men, aged 18-50 years old
• Women, aged 18-50 years old

Exclusion Criteria

• Non-lactating women, aged 18-50 years old
• Non-pregnant women, aged 18-50 years old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	SLV-313 SR	-
4	SLV-313 SR	-
3	SLV-313 SR	-
1	SLV-313 SR	-

Primary Outcome Measures

Name	Time	Method
Observe safety and tolerability	25 days

Secondary Outcome Measures

Name	Time	Method
PK and PD profile	25 days