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NCT03860506 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03860506
Other study ID # 3165A1-1108
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 1, 2008
Est. completion date July 1, 2008

Study information
Verified date February 2019
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Other known NCT identifiers
  • NCT00719069

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 1, 2008
Est. primary completion date July 1, 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• PSI-697

• Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Outcome
Type Measure Description Time frame Safety issue
Primary reduction of platelet monocyte aggregates 2 days
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