- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01042964
Safety, Pharmacokinetic and -Dynamic Study of PR-15, an Inhibitor of Platelet Adhesion (PR-15/01)
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
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Saxony
-
Goerlitz, Saxony, Germany, 02826
- ABX-CRO/Medifacts GmbH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard Piechatzek, MD, ABX-CRO/Medifacts GmbH
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR-15/01
- EudraCT 2005-004656-12 (REGISTRY: EudraCT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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