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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6482 | Drug | 0,9-364,5 mg administrated through intravenous infusion over 3 hours |
| |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Hartford, MD | AstraZeneca R&D, Clinical Pharmacology Unit, Sahlgrenska University Hospital, Göteborg, Sweden | Principal Investigator |
| Brian Bryzinski, MD | AstraZeneca Wilmington, DE United States | Study Chair |
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| ID | Term |
|---|---|
| C578518 | 2-(1-(7-methyl-2-morpholin-4-yl-4-oxo-4H-pyrido(1,2-a)pyrimidin-9-yl)ethylamino)benzoic acid |
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| Placebo |
| Drug |
|