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

• Conditions: 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.

• Registration Number: EUCTR2007-005695-14-GB
• Lead Sponsor: Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 30

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified