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

Pfizer18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Schizophrenia

Interventions

PF-00184562DRUG

OlanzapineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Pfizer Investigational Site

Austin, Texas, United States

Outcomes

Primary Outcomes

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.

Data from ClinicalTrials.gov

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