Study to Investigate Safety and Tolerability of a Single Dose of AZD6482

Study Overview
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Brief Summary
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AZD6482 is a new drug substance aiming to prevent blood clots which may arise in atherosclerotic blood vessels and cause myocardial infarction or stroke. This is the first study with AZD6482 in humans. The primary aim for this study is to evaluate the safety and tolerability of AZD6482 in healthy human volunteers. How the substance is metabolised and eliminated from the body will also be studied. This will be done by comparing the effect of single ascending doses of AZD6482 to placebo (inactive substance).

Official Title
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A Randomised, Double-Blind, Placebo-Controlled Phase I Study to Assess the Tolerability, Safety, Pharmacokinetic, and Pharmacodynamic Properties of AZD6482, Alone and co-Administered With ASA, After Single Ascending Intravenous Doses to Healthy Male Subjects

Conditions
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Antiplatelet Effect

Intervention / Treatment
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* Drug: AZD6482
* Drug: Placebo


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 administration of investigational product or clinically significant abnormalities in clinical chemistry, haematology, faeces, urinalysis or supine BP or pulse Known impaired glucose intolerance or known or suspected Gilbert´s syndrome

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD6482<br>* 0,9-364,5 mg administrated through intravenous infusion over 3 hours<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General safety and tolerability including adverse events, physical examination, vital signs, ECG parameters and laboratory variables |  | Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capillary Bleeding Time, Insulin and glucose homeostasis (HoMa-Index) |  | Prior to dose, repeatedly during 24 hrs after dose and at the follow-up visit 7-10 days after. | 
| Pharmacokinetics and inhibition of platelet aggregation |  | Prior to dose and repeatedly during 24 hrs after dose. | 

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