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The primary aim of this study is to investigate the safety and tolerabilty of AZD4017 when given as single oral ascending doses to Japanese healthy male volunters. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distrubution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected. The future indication for AZD4017 is planned to be Type 2 Diabetes Mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD4017 in ascending doses (start dose 2mg) |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4017 | Drug | ascending single doses (start dose 2 mg), oral suspension |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables | The variables will be measure predose and the repeatedly during the following 47 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal half-life, area under the plasma concentration-time curve and the apparent oral plasma clearance (CL/F) | Blood samples for determination of AZD4017 concentartion will be taken predose and repeatedly during the 47 hours post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shunji Matsuki | Kyusyu Clinical Phramacology Research Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fukuoka | Japan |
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| ID | Term |
|---|---|
| C574773 | 2-(1-(5-(cyclohexylcarbamoyl)-6-propylsulfanylpyridin-2-yl)-3-piperidyl)acetic acid |
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| Placebo |
| Drug |
placebo |
|