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

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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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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