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

This study has been completed.
Procorde GmbH
Information provided by (Responsible Party):
AdvanceCor GmbH Identifier:
First received: January 5, 2010
Last updated: October 18, 2012
Last verified: October 2012

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 Intervention Phase
Thrombosis Acute Coronary Syndrome Myocardial Infarction Stroke Drug: revacept (PR-15) Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by AdvanceCor GmbH:

Primary Outcome Measures:
  • 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 Measures:
  • pharmacokinetics and pharmacodynamics (agonist-induced platelet aggregation) [ Time Frame: 43 days ]

Enrollment: 30
Study Start Date: March 2006
Study Completion Date: October 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: revacept (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.
    Other Name: GPVI-Fc dimer
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


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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.
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Please refer to this study by its identifier: NCT01042964

ABX-CRO/Medifacts GmbH
Goerlitz, Saxony, Germany, 02826
Sponsors and Collaborators
AdvanceCor GmbH
Procorde GmbH
Principal Investigator: Richard Piechatzek, MD ABX-CRO/Medifacts GmbH
  More Information

Responsible Party: AdvanceCor GmbH Identifier: NCT01042964     History of Changes
Other Study ID Numbers: PR-15/01
EudraCT 2005-004656-12 ( Registry Identifier: EudraCT )
Study First Received: January 5, 2010
Last Updated: October 18, 2012

Keywords provided by AdvanceCor GmbH:
platelet adhesion and aggregation
acute coronary syndrome
myocardial infarction
inhibition of platelet adhesion to plaques
collagen-induced platelet aggregation

Additional relevant MeSH terms:
Myocardial Infarction
Acute Coronary Syndrome
Tissue Adhesions
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Fibrosis processed this record on August 23, 2017