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Study Evaluating Multiple Ascending Dose in Schizophrenia Patients

An Ascending Multiple-Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of SLV-313 Sustained-Release (SR) Tablets Administered Orally to Subjects With Schizophrenia and Schizoaffective Disorder

Status
Terminated
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00620568
Enrollment
32
Registered
2008-02-21
Start date
2008-02-29
Completion date
2008-03-31
Last updated
2009-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety, Tolerability, Schizophrenia

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.

Interventions

DRUGSLV-313 SR

sustained release tablets taken once daily for 14 days

Sponsors

Solvay Pharmaceuticals
CollaboratorINDUSTRY
Wyeth is now a wholly owned subsidiary of Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Observe safety and tolerability25 days

Secondary

MeasureTime frame
PK and PD profile25 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026