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Pre-Clinical Safety Tox Findings
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The main purpose of this study is to assess the safety and tolerability of AZD8418 after single increasing oral doses.
Another purpose of this study is to evaluate the pharmacokinetics (also called PK - how the study drug enters and leaves the body and how your body acts on the study drug) of AZD8418. Part B of the study will assess the effect of food on the safety and pharmacokinetics of AZD8418.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8418 | Drug | Single oral dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of AZD8418 following the oral administration of single ascending doses and to estimate the maximum tolerated dose in healthy volunteers. | Safety assessments will be obtained daily throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| To characterise the pharmacokinetics of AZD8418 and its metabolites in plasma and urine, and provisionally assess the dose proportionality of the pharmacokinetics following administration of single ascending doses of AZD8418. | samples will be obtained pre and post dose | |
| To assess the effect of food on the safety and pharmacokinetic profile of AZD8418 and its metabolites. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip T. Leese, M.D. | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
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| Drug |
single oral dose |
|
| samples will be obtained pre and post dose |