A Double-Blind, Placebo-Controlled, Randomized, Single-Dose, 2-Period Crossover Study of the Pharmacodynamics of Orally Administered PSI-697 in Healthy Subjects Who Smoke

Pfizer0 sites30 target enrollmentApril 1, 2008

ConditionsHealthy

InterventionsPSI-697 Placebo

DrugsPSI-697 Placebo

Overview

Phase: Phase 1
Intervention: PSI-697
Conditions: Healthy
Sponsor: Pfizer
Enrollment: 30
Primary Endpoint: reduction of platelet monocyte aggregates
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a single dose inpatient and outpatient study to test whether an effect on the ability of platelets to stick to white blood cells in subjects who smoke.

Registry

clinicaltrials.gov

Start Date

April 1, 2008

End Date

July 1, 2008

Last Updated

7 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Inclusion Criteria:
•Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12?lead electrocardiogram (ECG).
•Smoker of at least 1 pack or more of cigarettes per day (20 plus or minus 3 cigarettes) for more than 1 year as determined by history.

Exclusion Criteria

•Exclusion Criteria:
•Any diagnosed bleeding disorder.
•Any major surgical procedure within 6 months before study day
•Any history of major bleeding (eg, bleeding peptic ulcer) within 1 year before study day 1.