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

This study has been completed.
Sponsor:
Collaborator:
Procorde GmbH
Information provided by (Responsible Party):
AdvanceCor GmbH
ClinicalTrials.gov Identifier:
NCT01042964
First received: January 5, 2010
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • pharmacokinetics and pharmacodynamics (agonist-induced platelet aggregation) [ Time Frame: 43 days ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042964

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

Publications:
Responsible Party: AdvanceCor GmbH
ClinicalTrials.gov Identifier: NCT01042964     History of Changes
Other Study ID Numbers: PR-15/01, EudraCT 2005-004656-12
Study First Received: January 5, 2010
Last Updated: October 18, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)
Germany: Ethics Committee of Saxony

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

Additional relevant MeSH terms:
Acute Coronary Syndrome
Infarction
Myocardial Infarction
Syndrome
Thrombosis
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Embolism and Thrombosis
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014