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Study Evaluating Safety and Tolerability of Ascending Multiple Dose of SLV-313 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
NCT00581243
Enrollment
32
Registered
2007-12-27
Start date
2008-01-01
Completion date
2008-05-01
Last updated
2022-05-03

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

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

Interventions

DRUGSLV-313 SR

sustained relase 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