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The purpose of this study is to assess the relative bioavailability by measuring the extent and rate of absorption of different tablet formulations of AZD1656 in T2DM patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD1656 |
|
| 2 | Experimental | AZD1656 |
|
| 3 | Experimental | AZD1656 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1656 | Drug | 3 different formulations, A, B and C of AZD1656 assessed before food intake and formulation B also after food intake |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656. | Blood samples will be collected from predose to 48 hrs at each treatment period 1 | |
| Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656. | Blood samples will be collected from predose to 48 hrs at each treatment period 1 | |
| Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656. | Blood samples will be collected from predose to 48 hrs at each treatment period 1 | |
| Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656. | Blood samples will be collected from predose to 48 hrs at each treatment period 2 | |
| Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656. | Blood samples will be collected from predose to 48 hrs at each treatment period 2 | |
| Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of AZD1656 by assessing a panel of adverse events measures: physical examination, electrocardiogram, pulse and blood pressure, weight and laboratory, variables including plasma glucose. | start of treatment until follow up | |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Johnsson, MD, PhD | AstraZeneca Sweden | Study Director |
| Mark Matson, MD | Prism Research | Principal Investigator |
| Mirjana Kujacic Kujacic, MD, PhD | AstraZeneca R&D Mölndal | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Saint Paul | Minnesota | United States |
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| Blood samples will be collected from predose to 48 hrs at each treatment period 2 |
| Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656. | Blood samples will be collected from predose to 48 hrs at each treatment period 3 |
| Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656. | Blood samples will be collected from predose to 48 hrs at each treatment period 3 |
| Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656. | Blood samples will be collected from predose to 48 hrs at each treatment period 3 |
| Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656. | Blood samples will be collected from predose to 48 hrs at each treatment period 4 |
| Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656. | Blood samples will be collected from predose to 48 hrs at each treatment period 4 |
| Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656. | Blood samples will be collected from predose to 48 hrs at each treatment period 4 |
| PK blood samples will be collected from predose to 48 hrs after each treatment period 1 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t). | PK blood samples will be collected from predose to 48 hrs after each treatment period 1 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax. | PK blood samples will be collected from predose to 48 hrs after each treatment period 1 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax. | PK blood samples will be collected from predose to 48 hrs after each treatment period 1 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of t½. | PK blood samples will be collected from predose to 48 hrs after each treatment period 1 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC. | PK blood samples will be collected from predose to 48 hrs after each treatment period 2 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t). | PK blood samples will be collected from predose to 48 hrs after each treatment period 2 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax. | PK blood samples will be collected from predose to 48 hrs after each treatment period 2 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax. | PK blood samples will be collected from predose to 48 hrs after each treatment period 2 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of t½. | PK blood samples will be collected from predose to 48 hrs after each treatment period 2 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC. | PK blood samples will be collected from predose to 48 hrs after each treatment period 3 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t). | PK blood samples will be collected from predose to 48 hrs after each treatment period 3 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax. | PK blood samples will be collected from predose to 48 hrs after each treatment period 3 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax. | PK blood samples will be collected from predose to 48 hrs after each treatment period 3 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of t½. | PK blood samples will be collected from predose to 48 hrs after each treatment period 3 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC. | PK blood samples will be collected from predose to 48 hrs after each treatment period 4 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t). | PK blood samples will be collected from predose to 48 hrs after each treatment period 4 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax. | PK blood samples will be collected from predose to 48 hrs after each treatment period 4 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax. | PK blood samples will be collected from predose to 48 hrs after each treatment period 4 |
| Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of t½. | PK blood samples will be collected from predose to 48 hrs after each treatment period 4 |
| pharmacodynamics of AZD1656 following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-4) and AUC(0-24) for glucose | PK blood samples will be collected from predose to 48 hrs after treatment period and P-glucose on Day 1 of each treatment period |
| pharmacodynamics of AZD1656 following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-4) for insulin | PK blood samples will be collected from predose to 48 hrs after treatment period and P-glucose on Day 1 of each treatment period |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| 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 |
|---|---|
| C576407 | AZD1656 |
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