NCT00150215

Brief Summary

The purposes of this study are:

  • To determine the safety, tolerability and pharmacokinetics of single doses of PF-00184562; and
  • To explore the exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 schizophrenia

Timeline
Completed

Started Jul 2005

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

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

July 25, 2006

Status Verified

April 1, 2006

First QC Date

September 6, 2005

Last Update Submit

July 24, 2006

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (5)

  • Safety and tolerability of single dose PF-00184562 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs).

  • Pharmacokinetic profile of PF-00184562 maximum concentration (Cmax)

  • Time to obtain maximum concentration (tmax), area under concentration-time curve (AUC), and terminal half-life (t1/2).

  • Exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.

  • All measurements to be assessed over single doses.

Interventions

PF-00184562DRUG
OlanzapineDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female subjects of non-childbearing potential

You may not qualify if:

  • Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, active infections, immunological, or allergic disease (including drug allergies and seasonal allergies at time of dosing).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

July 1, 2005

Study Completion

October 1, 2005

Last Updated

July 25, 2006

Record last verified: 2006-04

Locations

US(1)