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

Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042964
• Other study ID #: PR-15/01
• Secondary ID: EudraCT 2005-004
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2010
• Last updated: October 18, 2012
• Start date: March 2006
• Est. completion date: October 2007

Study information

• Verified date: October 2012
• Source: AdvanceCor GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices (BfArM)Germany: Ethics Committee of Saxony
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Infarction
• Myocardial Infarction
• Stroke
• Thrombosis

Intervention

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.

Locations

Country	Name	City	State
Germany	ABX-CRO/Medifacts GmbH	Goerlitz	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
AdvanceCor GmbH	Procorde GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Ungerer M, Rosport K, Bültmann A, Piechatzek R, Uhland K, Schlieper P, Gawaz M, Münch G. Novel antiplatelet drug revacept (Dimeric Glycoprotein VI-Fc) specifically and efficiently inhibited collagen-induced platelet aggregation without affecting general h — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and tolerability adverse events (AEs), vital signs (BP/PR), 12 lead ECG, bleeding time, antibody titer and safety laboratory tests		43 days	Yes
Secondary	pharmacokinetics and pharmacodynamics (agonist-induced platelet aggregation)		43 days	Yes