NCT00928551

Brief Summary

This study will compare two different formulations of vabicaserin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_1

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

June 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 11, 2009

Status Verified

September 1, 2009

Enrollment Period

3 months

First QC Date

June 24, 2009

Last Update Submit

September 10, 2009

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic parameters including plasma concentrations, Cmax, and AUC.

    2 months

Secondary Outcomes (1)

  • Safety assessment as measured by evaluating any reported adverse events, scheduled physical examinations, vital sign measurements, ECGs, and clinical laboratory results.

    2 months

Study Arms (1)

1

EXPERIMENTAL
Drug: vabicaserin

Interventions

vabicaserinDRUG
1

Eligibility Criteria

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

You may qualify if:

  • Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after investigational product administration.
  • Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

You may not qualify if:

  • Use of any investigational or prescription drug within 30 days before investigation product administration.
  • Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1.
  • Use of any over-the-counter drugs, including herbal supplements within 72 hours before study day 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Brighton, Massachusetts, 2135, United States

Location

MeSH Terms

Interventions

vabicaserin

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
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 24, 2009

First Posted

June 26, 2009

Study Start

June 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 11, 2009

Record last verified: 2009-09

Locations

US(1)