PSI-697 is an orally active inhibitor of the cellular adhesion molecule P-selectin that offers a unique, first in class mechanism for preventing the vascular atherothrombotic state that is driven by the accumulation leukocytes and platelets in the vascular wall.
Conditions
Interventions
Product Name: PSI-697
Product Code: PSI-697
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PSI-697
CAS Number: 851546-61-7
Current Sponsor code: PSI-697
Other descriptive name: 2-(4-chloroben
Sponsors
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Signed and dated an institutional review board (IRB)/independent ethics committee (IEC)-approved informed consent form before any study-specific screening procedures are performed. 2. Men, aged 18 to 55 years inclusive at screening. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration. 3. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight =50 kg. BMI is calculated by taking the subject’s weight, in kilograms, divided by the square of the subject’s average height, in meters, at screening: BMI = weight (kg)/[height (m)]2 4. 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). 5. Smoker of at least 1 pack or more of cigarettes per day (20 +/- 3 cigarettes) for > 1 year as determined by history. 6. Have a high probability for compliance with and completion of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Medical History 1. Presence or history of any disorder that may prevent the successful completion of the study. 2. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. 3. Any diagnosed bleeding disorder. 4. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article. 5. Any major surgical procedure within 6 months before study day 1. 6. Any history of major bleeding (eg, bleeding peptic ulcer) within 1 year before study day 1. 7. Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1. 8. History of drug abuse within 1 year before study day 1. 9. History of alcoholism within 1 year of day 1, admitted alcohol abuse, or consumption of more than 50 g of ethanol per day (12.5 cL glass of 10° [10%] wine = 12 g; 4 cL glass of aperitif; 42° [42%] whiskey = 17 g; 25 cL glass of 3° [3%] beer = 7.5 g; 25 cL glass of 6° [6%] beer = 15 g). Physical and Laboratory Findings 10. Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead ECGs, or clinical laboratory test results. 11. Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, and phencyclidine [PCP]). 12. Positive serologic findings for human immunodeficiency virus antibodies, hepatitis B surface antigen, and/or hepatitis C virus antibodies. Allergies and Adverse Drug Reactions 13. History of any clinically important drug allergy or adverse drug reaction. Prohibited Treatments 14. Use of any investigational or prescription drug within 30 days before test article administration. 15. Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or soda) or alcoholic beverages within 24 hours before study day 1 (period 1 and 2). 16. Consumption of grapefruit or grapefruit-containing products within 72 hours before study day 1 (period 1 and 2). 17. Use of any over-the-counter drugs, including herbal supplements (except for the occasional use of paracetamol and vitamins =100% of the recommended daily allowance) within 14 days before study day 1 (period 1). 18. Donation of blood within 90 days before study day 1. Others 19. Total annual amount of compensation earned from participating in clinical trials exceeding 3200 stirling pounds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the pharmacodynamics (PD) of a single oral dose of PSI-697 in healthy subjects who smoke.;Secondary Objective: To obtain additional safety and pharmacokinetics (PK) data concerning PSI-697in healthy subjects who smoke.;Primary end point(s): To determine the effect of a single, 600-mg oral dose of PSI-697 on platelet monocyte aggregates in healthy volunteers who smoke | — |
Countries
United Kingdom
Outcome results
None listed