Back to resultsA First In Human Study Of PF-00184562 In Healthy Volunteers
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-00184562
Olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria: Healthy male or female subjects of non-childbearing potential Exclusion Criteria: 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).
Sites / Locations
- Pfizer Investigational Site
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00150215
First Posted
September 6, 2005
Last Updated
July 24, 2006
Sponsor
Pfizer
Collaborators
PPD
1. Study Identification
Unique Protocol Identification Number
NCT00150215
Brief Title
A First In Human Study Of PF-00184562 In Healthy Volunteers
Official Title
An Oral, Rising Single-Dose Tolerance, Pharmacokinetic, and Pharmacodynamic Study of Pf-00184562 Capsules In Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
Collaborators
PPD
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
18 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PF-00184562
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Primary Outcome Measure Information:
Title
Safety and tolerability of single dose PF-00184562 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs).
Title
Pharmacokinetic profile of PF-00184562 maximum concentration (Cmax)
Title
Time to obtain maximum concentration (tmax), area under concentration-time curve (AUC), and terminal half-life (t1/2).
Title
Exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.
Title
All measurements to be assessed over single doses.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male or female subjects of non-childbearing potential
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
12. IPD Sharing Statement
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A First In Human Study Of PF-00184562 In Healthy Volunteers
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