NCT00620568

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.

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 Feb 2008

Shorter than P25 for phase_1 healthy

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

Study Start

First participant enrolled

February 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

August 4, 2009

Status Verified

August 1, 2009

Enrollment Period

29 days

First QC Date

February 8, 2008

Last Update Submit

August 3, 2009

Conditions

Healthy

Keywords

SafetyTolerabilitySchizophrenia

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
Drug: SLV-313 SR

2

EXPERIMENTAL
Drug: SLV-313 SR

3

EXPERIMENTAL
Drug: SLV-313 SR

4

EXPERIMENTAL
Drug: SLV-313 SR

Interventions

SLV-313 SRDRUG

sustained release 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

Study Record Dates

First Submitted

February 8, 2008

First Posted

February 21, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

August 4, 2009

Record last verified: 2009-08