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

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. Identifier: NCT00150215
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : July 25, 2006
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: PF-00184562 Drug: Olanzapine Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 18 participants
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
Study Start Date : July 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Olanzapine

Primary Outcome Measures :
  1. Safety and tolerability of single dose PF-00184562 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs).
  2. Pharmacokinetic profile of PF-00184562 maximum concentration (Cmax)
  3. Time to obtain maximum concentration (tmax), area under concentration-time curve (AUC), and terminal half-life (t1/2).
  4. Exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.
  5. All measurements to be assessed over single doses.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).

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 identifier (NCT number): NCT00150215

United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer Identifier: NCT00150215     History of Changes
Other Study ID Numbers: A6241001
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: July 25, 2006
Last Verified: April 2006

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
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