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

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ClinicalTrials.gov Identifier: NCT03860506
Recruitment Status : Completed
First Posted : March 4, 2019
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: PSI-697 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 1, 2008
Actual Primary Completion Date : July 1, 2008
Actual Study Completion Date : July 1, 2008

Arm Intervention/treatment
Experimental: PSI-697 Drug: PSI-697
Placebo Comparator: Placebo Drug: Placebo



Primary Outcome Measures :
  1. reduction of platelet monocyte aggregates [ Time Frame: 2 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 1.
  • Any history of major bleeding (eg, bleeding peptic ulcer) within 1 year before study day 1.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860506


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03860506     History of Changes
Obsolete Identifiers: NCT00719069
Other Study ID Numbers: 3165A1-1108
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019

Keywords provided by Pfizer:
healthy subjects who smoke
healthy subjects