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Trial record 1 of 1 for:    NCT00150215
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A First In Human Study Of PF-00184562 In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00150215
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : July 25, 2006
Sponsor:
Collaborator:
PPD
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 6, 2005
First Posted Date  ICMJE September 8, 2005
Last Update Posted Date July 25, 2006
Study Start Date  ICMJE July 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2006)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 6, 2005)
  • 1) Safety and tolerability of single dose PF-00184562 as determined by adverse event reporting, clinical laboratory results, vital signs, physical examinations, and ECGs.
  • 2)Pharmacokinetic profile of PF-00184562 maximum concentration (Cmax), time to obtai
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A First In Human Study Of PF-00184562 In Healthy Volunteers
Official Title  ICMJE An Oral, Rising Single-Dose Tolerance, Pharmacokinetic, and Pharmacodynamic Study of Pf-00184562 Capsules In Healthy Volunteers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: PF-00184562
  • Drug: Olanzapine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 6, 2005)
18
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00150215
Other Study ID Numbers  ICMJE A6241001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE PPD
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP