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Part A reached a predefined stopping criteria. Relevant doses for part B could not be established based on A and subsequently study was stopped.
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The purpose of this study is to assess safety and tolerability of AZD6714 after single ascending oral doses in healthy male subjects and type 2 diabetic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD6714 in 8 increasing oral single doses a-h given to 8 groups (3 on active and 1 on placebo in each group) |
|
| 2 | Experimental | 2 oral single doses d and g suspensions of AZD6714 given to 2 groups (3+1) together with food |
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| 3 | Experimental | Two increasing oral doses of AZD6714 and one placebo given to 2 groups with 3 type 2 diabetic patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD6714 | Drug | Oral single doses a-h suspension |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG) | AEs will be collected during the whole study period (1-3 months). The other variables will be measured repeatedly during 24 hours on the study day sessions |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables | Blood samples taken repeatedly during 24 hours on study day sessions. | |
| Pharmacodynamic variables (P-Glucose, S-Insulin and C-peptide) | Blood samples taken repeatedly during 24 hours on study day sessions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klas Malmberg, MD, PhD | AstraZeneca R&D Mölndal | Study Director |
| Marianne Hartford | CPU Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gothenburg | Sweden |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Drug |
Oral single doses suspension |
|
| AZD6714 | Drug | Oral single doses a-d suspension |
|
| AZD6714 | Drug | Oral single doses d and g suspension |
|
| D004700 | Endocrine System Diseases |