NCT00541996

Brief Summary

The purpose of this study is to determine the absorption rate of four oral formulations of vabicaserin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed
Last Updated

December 5, 2007

Status Verified

December 1, 2007

First QC Date

October 5, 2007

Last Update Submit

December 3, 2007

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Assess the bioavailability of four oral formulations of vabicaserin.

Secondary Outcomes (1)

  • Obtain additional safety and tolerability data for vabicaserin in healthy male subjects.

Interventions

vabicaserinDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men aged 18-50 years.

You may not qualify if:

  • Any significant disease state.
  • History of drug or alcohol abuse within 1 year.
  • Abnormal liver function tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Philadelphia, Pennsylvania, 19148, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

vabicaserin

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
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 5, 2007

First Posted

October 10, 2007

Study Start

August 1, 2007

Study Completion

October 1, 2007

Last Updated

December 5, 2007

Record last verified: 2007-12

Locations

US(1)