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Study Evaluating Multiple Ascending Dose in Schizophrenia Patients

Primary Purpose

Healthy

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SLV-313 SR
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy focused on measuring Safety, Tolerability, Schizophrenia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    1

    2

    3

    4

    Arm Description

    Outcomes

    Primary Outcome Measures

    Observe safety and tolerability

    Secondary Outcome Measures

    PK and PD profile

    Full Information

    First Posted
    February 8, 2008
    Last Updated
    August 3, 2009
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
    Collaborators
    Solvay Pharmaceuticals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00620568
    Brief Title
    Study Evaluating Multiple Ascending Dose in Schizophrenia Patients
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2009
    Overall Recruitment Status
    Terminated
    Study Start Date
    February 2008 (undefined)
    Primary Completion Date
    March 2008 (Actual)
    Study Completion Date
    March 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
    Collaborators
    Solvay Pharmaceuticals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy
    Keywords
    Safety, Tolerability, Schizophrenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    32 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Experimental
    Arm Title
    3
    Arm Type
    Experimental
    Arm Title
    4
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    SLV-313 SR
    Intervention Description
    sustained release tablets taken once daily for 14 days
    Primary Outcome Measure Information:
    Title
    Observe safety and tolerability
    Time Frame
    25 days
    Secondary Outcome Measure Information:
    Title
    PK and PD profile
    Time Frame
    25 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Wyeth is now a wholly owned subsidiary of Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Study Evaluating Multiple Ascending Dose in Schizophrenia Patients

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