Influence of Clopidogrel on the Pharmacodynamics and Safety of Fradafiban in Healthy Male Subjects

Study Overview
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Brief Summary
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To assess the influence of 75 mg Clopidogrel on the pharmacodynamics and safety of 30 mg Lefradafiban tid

Official Title
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Influence of Oral Doses of 75 mg Clopidogrel on the Pharmacodynamics and Safety of Fradafiban After Oral Doses of 30 mg Lefradafiban Tid Over 8 Days in Healthy Male Subjects. An Intra-individual, Open Trial.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Lefradafiban
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent in accordance with good clinical practice (GCP) and local legislation Healthy male subjects Age ≥ 18 and ≤ 45 years Broca ≥ - 20 % and ≤ + 20 % Exclusion Criteria: Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders Diseases of the central nervous system (such as epilepsy) or psychiatric disorders Chronic or relevant acute infections History of Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator Any bleeding disorder including prolonged or habitual bleeding Other hematologic disease Cerebral bleeding (e.g. after a car accident Commotio cerebri Intake of drugs with a long half-life (> 24 hours) within 1 month prior to administration Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial Participation in another trial with an investigational drug within 2 months prior to administration or during the trial Smoker (> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days Alcohol abuse (> 60 g/day) Drug abuse Blood donation within 1 month prior to administration or during the trial Excessive physical activities within 5 days prior to administration or during the trial Any laboratory value outside the clinically accepted reference range History of any familial bleeding disorder Thrombocytes < 150000/µl

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lefradafiban with clopidogrel<br>All patients received the same treatment: Lefradafiban only (day 1-4) Lefradafiban in combination with Clopidogrel (day 5-8) Clopidogrel only (day 9-12) | Drug: Lefradafiban<br> <br> Drug: Clopidogrel<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhibition of platelet aggregation in platelet rich plasma (PRP) |  | Up to 383:30 hours after first drug administration | 
| Fibrinogen receptor occupancy levels (FRO) |  | Up to 383:30 hours after first drug administration | 
| Maximum concentration of the analyte in plasma at steady state (Cmax) |  | Up to 383:30 hours after first drug administration | 
| Area under the concentration-time curve of the analyte in plasma (AUC) |  | Up to 383:30 hours after first drug administration | 
| Amount of the analyte excreted unchanged in the urine (Ae) |  | Up to 176:00 hours after first drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events |  | up to 5 days after last drug administration | 
| Changes from baseline in 12-lead ECG |  | Pre-dose and 384:30 hours after first drug administration | 
| Number of subjects with clinically significant findings in vital signs | systolic and diastolic blood pressure, pulse rate | up to 5 days after last drug administration | 
| Changes from baseline in bleeding time |  | Pre-dose and 384:30 hours after first drug administration |