Study Evaluating Safety and Tolerability of Ascending Multiple Dose of SLV-313 in Schizophrenia Patients

April 28, 2022 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
2 mg SLV-313 SR (fixed dose)
Drug: SLV-313 SR
sustained relase tablets taken once daily for 14 days
Experimental: 2
5 mg SLV-313 SR (fixed dose)
Drug: SLV-313 SR
sustained relase tablets taken once daily for 14 days
Experimental: 3
10 mg SLV-313 SR (fixed dose)
Drug: SLV-313 SR
sustained relase tablets taken once daily for 14 days
Experimental: 4
xx mg SLV-313 SR (titration)
Drug: SLV-313 SR
sustained relase tablets taken once daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Observe safety and tolerability
Time Frame: 25 days
25 days

Secondary Outcome Measures

Outcome Measure
Time Frame
PK and PD profile
Time Frame: 25 days
25 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2008

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

December 27, 2007

Study Record Updates

Last Update Posted (Actual)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 28, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3170A1-01001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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