Acute Coronary Syndrome, Myocardial Infarction, Stroke, Thrombosis
Conditions
Keywords
platelet adhesion and aggregation, acute coronary syndrome, myocardial infarction, stroke, inhibition of platelet adhesion to plaques, collagen-induced platelet aggregation
Brief 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
Detailed description
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
Interventions
DRUGrevacept (PR-15)
single intravenous administration of revacept (PR-15), an inhibitor of platelet adhesion, in various strengths (10, 20, 40, 80, 160 mg) in healthy male volunteers.
Sponsors
Procorde GmbH
AdvanceCor GmbH
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and tolerability adverse events (AEs), vital signs (BP/PR), 12 lead ECG, bleeding time, antibody titer and safety laboratory tests | 43 days |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics and pharmacodynamics (agonist-induced platelet aggregation) | 43 days |
Countries
Germany
Outcome results
None listed