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

October 18, 2012 updated by: AdvanceCor GmbH

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: revacept (PR-15)

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

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- Saxony
  - Goerlitz, Saxony, Germany, 02826
    - ABX-CRO/Medifacts GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	43 days

Secondary Outcome Measures

Outcome Measure	Time Frame
pharmacokinetics and pharmacodynamics (agonist-induced platelet aggregation) Time Frame: 43 days	43 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdvanceCor GmbH

Collaborators

Procorde GmbH

Investigators

Principal Investigator: Richard Piechatzek, MD, ABX-CRO/Medifacts GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

January 1, 2007

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria