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

Primary Purpose

Thrombosis, Acute Coronary Syndrome, Myocardial Infarction

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

revacept (PR-15)

About this trial

This is an interventional treatment trial for Thrombosis focused on measuring platelet adhesion and aggregation, acute coronary syndrome, myocardial infarction, stroke, inhibition of platelet adhesion to plaques, collagen-induced platelet aggregation

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

ABX-CRO/Medifacts GmbH

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

pharmacokinetics and pharmacodynamics (agonist-induced platelet aggregation)

Full Information

NCT ID

NCT01042964

First Posted

January 5, 2010

Last Updated

October 18, 2012

Sponsor

AdvanceCor GmbH

Collaborators

Procorde GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01042964

Brief Title

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

Acronym

PR-15/01

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

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

January 2007 (Actual)

Study Completion Date

October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AdvanceCor GmbH

Collaborators

Procorde GmbH

4. Oversight

Data Monitoring Committee

Yes

5. 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

revacept (PR-15)

Other Intervention Name(s)

GPVI-Fc dimer

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

43 days

Secondary Outcome Measure Information:

Title

pharmacokinetics and pharmacodynamics (agonist-induced platelet aggregation)

Time Frame

43 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Piechatzek, MD

Organizational Affiliation

ABX-CRO/Medifacts GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

ABX-CRO/Medifacts GmbH

City

Goerlitz

State/Province

Saxony

ZIP/Postal Code

02826

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

21502572

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.

Results Reference

result

Learn more about this trial

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

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