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The study pharmacodynamic stopping criteria were met after the first dosing group
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The purpose of this study is to evaluate the safety and tolerability of AZD8165 and the pharmacokinetics of the metabolite AZ12971554 and plasma levels of the prodrug AZD8165 after escalating single oral low doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8165 | Drug | Oral suspension, 2 mg/mL and 20 mg/mL, single doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (adverse events, Electrocardiograms, vital signs, safety labs) | Approximately 64 days including a screening period, 3 treatment periods, 2 washout periods, and a follow-up period. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma and urine levels of AZD8165 and its active metabolite AZ12971554 | Serial blood and urine samples will be taken over 24 hours after oral administration to evaluate AZD8165 and its active metabolite AZ12971554 | |
| Coagulation times (namely Activated Partial Thromboplastin Time,Ecarin Clotting Time, Thrombin Clotting Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph Schutz, MD | Quintiles, Inc. | Principal Investigator |
| Peter Held | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
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| Serial blood samples will be taken over 24 hours after oral administration to evaluate Activated Partial Thromboplastin Time (APTT), Ecarin clotting Time (ECT), Thrombin Clotting Time (TCT) |