NCT00581243

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2008

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

December 21, 2007

Last Update Submit

April 28, 2022

Conditions

Healthy

Keywords

Safety,Tolerability, Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Observe safety and tolerability

    25 days

Secondary Outcomes (1)

  • PK and PD profile

    25 days

Study Arms (4)

1

EXPERIMENTAL

2 mg SLV-313 SR (fixed dose)

Drug: SLV-313 SR

2

EXPERIMENTAL

5 mg SLV-313 SR (fixed dose)

Drug: SLV-313 SR

3

EXPERIMENTAL

10 mg SLV-313 SR (fixed dose)

Drug: SLV-313 SR

4

EXPERIMENTAL

xx mg SLV-313 SR (titration)

Drug: SLV-313 SR

Interventions

SLV-313 SRDRUG

sustained relase tablets taken once daily for 14 days

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Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 27, 2007

Study Start

January 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

May 3, 2022

Record last verified: 2022-04