Clinical trial NCT01042964: Safety, Pharmacokinetic and -Dynamic Study of PR-15, an Inhibitor of Platelet Adhesion
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombosis
Acute Coronary Syndrome
Myocardial Infarction
Stroke
Keywords: platelet adhesion and aggregation
acute coronary syndrome
myocardial infarction
stroke
inhibition of platelet adhesion to plaques
collagen-induced platelet aggregation
Lead sponsor: AdvanceCor GmbH
Sponsor class: INDUSTRY
Collaborators: name: Procorde GmbH
First posted: 2010-01-06
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: safety and tolerability adverse events (AEs), vital signs (BP/PR), 12 lead ECG, bleeding time, antibody titer and safety laboratory tests
timeFrame: 43 days
Secondary outcomes:
measure: pharmacokinetics and pharmacodynamics (agonist-induced platelet aggregation)
timeFrame: 43 days
Other outcomes:
Locations:
city: Goerlitz
country: Germany
facility: ABX-CRO/Medifacts GmbH
state: Saxony
Study officials:
affiliation: ABX-CRO/Medifacts GmbH
name: Richard Piechatzek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ungerer M, Rosport K, Bultmann A, Piechatzek R, Uhland K, Schlieper P, Gawaz M, Munch G. Novel antiplatelet drug revacept (Dimeric Glycoprotein VI-Fc) specifically and efficiently inhibited collagen-induced platelet aggregation without affecting general hemostasis in humans. Circulation. 2011 May 3;123(17):1891-9. doi: 10.1161/CIRCULATIONAHA.110.980623. Epub 2011 Apr 18.