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

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: July 2, 2008
Last updated: July 21, 2008
Last verified: July 2008

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
Drug: PSI-697
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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
Experimental: active/placebo Drug: PSI-697


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

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 identifier: NCT00719069

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

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

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
healthy subjects who smoke
healthy subjects processed this record on April 17, 2014