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

NCT ID: NCT00150215

Last Updated: 2006-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2005-10-31

Brief Summary

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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

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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PF-00184562

Intervention Type DRUG

Olanzapine

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PPD Development, LP

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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A6241001

Identifier Type: -

Identifier Source: org_study_id