CClinicalTrials.gg
TerminatedNCT00620568Updated Aug 4, 2009

Study Evaluating Multiple Ascending Dose in Schizophrenia Patients

A Phase 1 interventional study of SLV-313 SR in Healthy, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Terminated. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2009-08-04.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

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Keywords

  • Safety
  • Tolerability
  • Schizophrenia
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's planned enrollment of 32 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Non-lactating women, aged 18-50 years old
  • Non-pregnant women, aged 18-50 years old
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    1

    Drug: SLV-313 SR

  • Experimental
    2

    Drug: SLV-313 SR

  • Experimental
    3

    Drug: SLV-313 SR

  • Experimental
    4

    Drug: SLV-313 SR

Interventions

  • DrugSLV-313 SR

    sustained release tablets taken once daily for 14 days

06

What researchers measure

Primary outcomes

  1. Observe safety and tolerability

    Time frame: 25 days

Secondary outcomes

  1. PK and PD profile

    Time frame: 25 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00620568
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators
Solvay Pharmaceuticals
First posted
Feb 21, 2008
Start date
Feb 2008
Primary completion
Mar 2008
Completion
Mar 2008
Last update
Aug 4, 2009

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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