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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PSI-697; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03860506

3165A1-1108

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

PSI-697

Experimental group

Treatment:

Drug: PSI-697

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo