PR-15/01: Safety, Pharmacokinetic and -Dynamic Study of PR-15, an Inhibitor of Platelet Adhesion

Sponsor

AdvanceCor GmbH (Industry)

Overall Status

Completed

CT.gov ID

NCT01042964

Collaborator

Procorde GmbH (Other)

Enrollment

Location

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Thrombosis Acute Coronary Syndrome Myocardial Infarction Stroke	Drug: revacept (PR-15)	Phase 1

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

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label, Dose-Escalating Safety and Pharmacokinetic Study of an Acute Intravenous Administration of PR-15, an Inhibitor of Platelet Adhesion, in Six Different Strengths in Healthy Male Volunteers

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Jan 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Outcome Measures

Primary Outcome Measures

safety and tolerability adverse events (AEs), vital signs (BP/PR), 12 lead ECG, bleeding time, antibody titer and safety laboratory tests [43 days]

Secondary Outcome Measures

pharmacokinetics and pharmacodynamics (agonist-induced platelet aggregation) [43 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts 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.