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A First In Human Study Of PF-00184562 In Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
PPD
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00150215
First received: September 6, 2005
Last updated: July 24, 2006
Last verified: April 2006
History of Changes
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00150215     History of Changes
Other Study ID Numbers: A6241001
Study First Received: September 6, 2005
Last Updated: July 24, 2006
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 22, 2013