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

NCT01042964 | Completed Phase 1 DMC

• 2 other identifiers: PR-15/01EudraCT 2005-004656-12
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

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

  43 days

Secondary Outcomes (1)

• pharmacokinetics and pharmacodynamics (agonist-induced platelet aggregation)

  43 days

Interventions

revacept (PR-15) DRUG

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.

Also known as: GPVI-Fc dimer

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AdvanceCor GmbH: lead
• Procorde GmbH: collaborator

Study Sites (1)

ABX-CRO/Medifacts GmbH

Görlitz, Saxony, 02826, Germany

Location

Related Publications (1)

• 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.

  PMID: 21502572 RESULT

MeSH Terms

Conditions

Thrombosis; Acute Coronary Syndrome; Myocardial Infarction; Stroke

Interventions

Revacept

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Richard Piechatzek, MD

  ABX-CRO/Medifacts GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2010
• First Posted: January 6, 2010
• Study Start: March 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: October 1, 2007
• Last Updated: October 19, 2012

Record last verified: 2012-10

Locations

DE (1)