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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00150215
First Posted: September 8, 2005
Last Update Posted: July 25, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
PPD
Information provided by:
Pfizer
  Purpose

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.

Condition Intervention Phase
Schizophrenia Drug: PF-00184562 Drug: Olanzapine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An Oral, Rising Single-Dose Tolerance, Pharmacokinetic, and Pharmacodynamic Study of Pf-00184562 Capsules In Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

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.

Estimated Enrollment: 18
Study Start Date: July 2005
Estimated Study Completion Date: October 2005
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00150215


Locations
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
Pfizer
PPD
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

ClinicalTrials.gov Identifier: NCT00150215     History of Changes
Other Study ID Numbers: A6241001
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: July 25, 2006
Last Verified: April 2006

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Olanzapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents