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Completed

NCT Number: NCT03860506

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

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.

Completed

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PSI-697

Drug

Placebo

Drug

Primary outcomes

  1. reduction of platelet monocyte aggregates

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 4, 2019
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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