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

Back to Search
Print
Bookmark Trial

NCT00581243

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men, aged 18-50 years old

- Women, aged 18-50 years old

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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


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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

HealthyStudy Of Safety, Tolerability And Pharmacokinetics Of Subcutaneous Doses Of TA-46 NCT04410809
  1. Groningen,
ALL GENDERS
21 Years+
years
MULTIPLE SITES
HealthyPK and Bioavailability Comparison of Tofacitinib Between a Modified Release and The Immediate Release Formulation NCT04403776
  1. Shanghai,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
HealthyA Bioequivalence Study of Sildenafil Citrate Orally-Disintegrating Film Dosage Form NCT04391868
Male
18 Years+
years
MULTIPLE SITES
HealthyStudy Of Single And Multiple Ascending Doses Of PF-07054894 In Healthy Adult Participants NCT04388878
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Safety and Tolerability of Ascending Multiple Dose of SLV-313 in Schizophrenia Patients
Official Title  ICMJE 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
Brief Summary Randomized, inpatient, ascending multiple dose study given to subjects with schizophrenia and schizoaffective disorder to assess safety and tolerability.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: SLV-313 SR
sustained relase tablets taken once daily for 14 days
Study Arms  ICMJE
  • Experimental: 1
    2 mg SLV-313 SR (fixed dose)
    Intervention: Drug: SLV-313 SR
  • Experimental: 2
    5 mg SLV-313 SR (fixed dose)
    Intervention: Drug: SLV-313 SR
  • Experimental: 3
    10 mg SLV-313 SR (fixed dose)
    Intervention: Drug: SLV-313 SR
  • Experimental: 4
    xx mg SLV-313 SR (titration)
    Intervention: Drug: SLV-313 SR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: December 21, 2007)		32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2008
Estimated Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00581243
Other Study ID Numbers  ICMJE 3170A1-01001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Solvay Pharmaceuticals
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP