Study Evaluating Safety and Tolerability of Ascending Multiple Dose of SLV-313 in Schizophrenia Patients

Phase 1

Terminated

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

• Registration Number: NCT00581243
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

Randomized, inpatient, ascending multiple dose study given to subjects with schizophrenia and schizoaffective disorder to assess safety and tolerability.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2007-12-27
• Study Start: 2008-01-01
• Primary Completion: 2008-05-01
• Study Completion: 2008-05-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-28
• Last Update Posted: 2022-05-03

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
1	SLV-313 SR	2 mg SLV-313 SR (fixed dose)
2	SLV-313 SR	5 mg SLV-313 SR (fixed dose)
3	SLV-313 SR	10 mg SLV-313 SR (fixed dose)
4	SLV-313 SR	xx mg SLV-313 SR (titration)

Primary Outcome Measures

Name	Time	Method
Observe safety and tolerability	25 days

Secondary Outcome Measures

Name	Time	Method
PK and PD profile	25 days