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The primary aim of this study is to investigate the safety and tolerability of AZD4017 when given as multiple oral ascending doses to healthy volunteers. This will be done by comparing the effect of AZD4017 to placebo. The study will aslo investigate the absorption, distribution and disappearance of AZD4017 in the body. Information about plasma concentrations of AZD4017 vs time after dose intake will also be collected and some measures of pharmacokinetics versus pharmacodynamics will be included. 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 75mg od) |
|
| 2 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4017 | Drug | ascending multiple doses(start dose 75mg od), oral suspension |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability (Adverse events, vital signs, ECGs, physical examination, laboratory variables | The variables will be measured predose and then repeatedly during the study |
| 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 concentration will be taken predose and repeatedly during the study. | |
| Laboratory screen to evaluate effect on metabolic variables |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Hartford, MD PhD | AstraZeneca Clinical Pharmacolgy Unit Sahlgrenska University Hospital SE-413 45 Göteborg Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gothenburg | Sweden |
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| Placebo |
| Drug |
|
| Blood samples will be taken pre-dose and repeatedly during the study |
| Pharmacodynamic measurements allowing to assess AZD4017 effect in different tissues | Baseline and repeatedly after treatment |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C574773 | 2-(1-(5-(cyclohexylcarbamoyl)-6-propylsulfanylpyridin-2-yl)-3-piperidyl)acetic acid |
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