Safety, Pharmacokinetic and -Dynamic Study of PR-15, an Inhibitor of Platelet Adhesion

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AdvanceCor GmbH
• Collaborator: Procorde GmbH

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.