Bleeding Time Study With AZD6482, Clopidogrel and ASA

Study Overview
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Brief Summary
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The primary purpose of this study is to evaluate the effect of AZD6482 and clopidogrel on bleeding time when taken together with low-dose ASA.

Official Title
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A Randomised, Open-label, Single-Centre, Phase I, Crossover Study to Evaluate the Effect of AZD6482, Compared With Clopidogrel, on Bleeding Time in Healthy Volunteers Receiving Low-Dose ASA

Conditions
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Antiplatelet Effect

Intervention / Treatment
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* Drug: AZD6482
* Drug: Clopidogrel
* Drug: ASA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive Provision of written informed consent Exclusion Criteria: Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms. Acute illness, surgical procedure or trauma from 2 weeks before pre-entry visit until the first baseline visit or clinically significant abnormalities in clinical chemistry, haematology, urinalysis or supine BP or pulse Known impaired glucose tolerance, known galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or known or suspected Gilbert's syndrome

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD6482 on top of ASA | Drug: AZD6482<br>* Single intravenous infusion during a maximum of 5 hours<br>Drug: ASA<br>* 75 mg orally once daily during 7 days in each treatment arm<br>* Other names: Trombyl®;|
| Active Comparator: 2<br>Clopidogrel on top of ASA | Drug: Clopidogrel<br>* Oral doses given once daily during 7 days. 300 mg on day 1 and 75 mg on day 2 to 7.<br>* Other names: Plavix®;Drug: ASA<br>* 75 mg orally once daily during 7 days in each treatment arm<br>* Other names: Trombyl®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capillary Bleeding Time (CBT) |  | Prior to first dose in each treatment period, on study day 6 and 7 in treatment period A and on study day 7 in treatment period B | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on bleeding |  | Prior to first dose in each treatment period, twice on study day 6 and three times on study day 7 in treatment period A and twice on study day 7 in treatment period B | 
| Pharmacokinetics |  | Prior to AZD6482 infusion and repeatedly during 6 hours after end of infusion | 
| Safety variables (adverse events, blood pressure, pulse, ECG, safety lab) |  | Repeatedly during the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antiplatelet