Study Evaluating the Effects of PSI-697 on Platelets in Subjects Who Smoke

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PSI-697; Drug: Placebo

• Registration Number: NCT03860506
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-01
• Primary Completion: 2008-07-01
• Study Completion: 2008-07-01
• Study First Submitted: 2018-01-22
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-28
• Last Update Submitted: 2019-02-28
• Study First Posted: 2019-03-04
• Last Update Posted: 2019-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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 1.
• Any history of major bleeding (eg, bleeding peptic ulcer) within 1 year before study day 1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PSI-697	PSI-697	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
reduction of platelet monocyte aggregates	2 days