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

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00719069

Purpose

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	Intervention	Phase
Healthy	Drug: PSI-697	Phase I

MedlinePlus related topics: Smoking

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacodynamics Study
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

Further study details as provided by Wyeth:

Primary Outcome Measures:

reduction of platelet monocyte aggregates [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	April 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
active/placebo: Experimental	Drug: PSI-697

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

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:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00719069

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3165A1-1108
Study First Received:	July 2, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00719069
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Wyeth:

healthy subjects who smoke
healthy subjects

Study placed in the following topic categories:

Smoking
Healthy

ClinicalTrials.gov processed this record on January 13, 2009