safety, pharmacokinetic and -dynamic study of pr-15, an inhibitor of platelet adhesion

Conditions: Thrombosis; Acute Coronary Syndrome; Myocardial Infarction; Stroke

Summary: primary objective: to evaluate safety and tolerability, adverse events (aes), vital signs, ecg, bleeding time, evaluation of antibody titer and safety laboratory tests secondary objectives: to evaluate the pharmacokinetics and pharmacodynamics (platelet aggregation)of six ascending single intravenous doses of pr-15 in healthy volunteers

primary objective: to evaluate safety and tolerability by using adverse events (aes), vital signs including blood pressure/pulse rate (bp/pr), electrocardiographic examinations (12 lead ecg), bleeding time, evaluation of antibody titer and safety laboratory tests (biochemistry, hematology, coagulation, urinalysis) secondary objectives: to evaluate the pharmacokinetics and pharmacodynamics (collagen-induced platelet aggregation)of six ascending single intravenous doses of pr-15 in healthy, male volunteers

Eligibility criteria:
inclusion criteria: * healthy, male caucasians between 18 and 45 years of age. * normotensive subjects (systolic bp \< 140 mmhg and diastolic bp \<90 mmhg; * body weight of 70 to 90 kg (bmi 20 - 25. * negative results in hiv antibody, hbs antigen (hbsag) and hcv tests; * signed informed consent form. * normal coagulation function (aptt between 24 and 35 seconds, pt between 70 and 130%, inr between 0.85 and 1.15. exclusion criteria: * subjects who are taking or have taken any prescription medication within the last 14 days or any non-prescription medication, especially, anti-platelet drugs, within the last seven days prior to the administration of trial medication on day 1. * intake of any investigational drug within three months prior to the administration of study medication on day 1. * concomitant use of any other medication including over-the-counter preparations. * history of hypersensitivity, contraindication or serious adverse reaction to inhibitors of platelet aggregation or hypersensitivity to related drugs (cross-allergy) or to any of the excipients in the study drug. * a history or clinical evidence of any cardiac, cardio- or cerebrovascular, hepatic, renal, pulmonary, endocrine, neurological, infectious, gastrointestinal, haematological, oncological or psychiatric disease or emotional problems or any other clinically relevant condition, physical finding, ecg- or laboratory test abnormality, which - in the opinion of the investigator - would pose a significant risk for the subject, invalidate the informed consent or limit the ability of the subject to comply with study requirements or interfere otherwise with the conduct of the study. * any laboratory value outside the normal laboratory reference range at screening and before randomization, unless approved by the investigator. * subjects known to have experienced elevated liver enzyme values will also be excluded. * history of alcohol and/or drug abuse (verified by drug screening). * blood loss of 450 ml or more during the last three months before screening. * subjects who smoke more than 5 cigarettes per day and/or are unable to abstain from smoking during the entire in-house period. * subjects who were previously enrolled in this trial or who have received pr-15 in a previous trial. * subjects who have participated in other clinical trials in the last 3 months.

Keywords: platelet adhesion and aggregation acute coronary syndrome myocardial infarction stroke inhibition of platelet adhesion to plaques collagen-induced platelet aggregation