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The purpose of this study is to determine the safety of AZD6765 when given in single and multiple oral doses and to compare an oral and intravenous (IV) formulation of AZD6765 to placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD6765 oral solution | Experimental | Active |
|
| AZD6765 IV infusion | Experimental | Active |
|
| Placebo to AZD6765 oral solution | Placebo Comparator | Placebo |
|
| Placebo to AZD6765 IV infusion | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6765 | Drug | Single oral dose and single IV infusion of AZD6765 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The objective of the study is to investigate the safety and tolerability of AZD6765 when administered orally in single and multiple doses to healthy subjects by assessment of adverse events, vital signs, physical examinations, electrocardiograms(ECG). | Safety assessments are made prior to and after drug administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A 1. To characterize the single dose pharmacokinetics of AZD67652. To assess the absolute bioavailability of AZD67653. To assess the effect of food on the pharmacokinetics of AZD6765 | Blood samples will be obtained on Days 1-5. | |
| Part B 1. To characterize the single and multiple dose pharmacokinetics of AZD6765 2. To assess dose linearity and proportionality of AZD67653. To assess the degree of accumulation and the time dependence of the pharmacokinetics of AZD6765 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip Leese, MD | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Overland Park | Kansas | United States |
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| ID | Term |
|---|---|
| C585977 | AZD6765 |
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| AZD6765 | Drug | Once-daily oral dose of AZD6765 or placebo on Day 1 and on Days 4 through 9. |
|
| Blood samples will be obtained on Days 1-4 and 7-11. |