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Completed

NCT Number: NCT00150215

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PF-00184562

Drug

Olanzapine

Drug

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • PPD Development, LP

Registry information

Official study title

An Oral, Rising Single-Dose Tolerance, Pharmacokinetic, and Pharmacodynamic Study of Pf-00184562 Capsules In Healthy Volunteers

Important dates

Study start
2005
Study completion
2005
First posted
Sep 8, 2005
Registry last updated
Jul 25, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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