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To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AZD1656 |
|
| 2 | Experimental | Simvastatin |
|
| 3 | Experimental | AZD1656 + simvastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1656 | Drug | Oral tablet, BID dose |
| |
| simvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of AZD1656 on the steady state pharmacokinetics of simvastatin (including simvastatin acid) and vice versa by assessment of AUC(0-24) and Cmax. | Frequent blood samples for PK analysis will be drawn during 24 hours post morning dose on day 4 in each treatment period (1-3) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effect of AZD1656 on the steady state pharmacokinetics of simvastatin and simvastatin acid and vice versa by assessment of tmax, t1/2 and CL/F (only for AZD1656) | Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3) | |
| To evaluate the steady state pharmacokinetics of the AZD1656 metabolite when AZD1656 is administered with and without simvastatin, by assessment of AUC(0-24), Cmax and tmax. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jolene K. Berg, MD | Cetero Research, Inc. | Principal Investigator |
| Stanko Skrtic | AstraZeneca | Study Director |
| Mirjana Kujacic | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | San Antonio | Texas | United States |
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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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| ID | Term |
|---|---|
| C576407 | AZD1656 |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Drug |
Oral tablet, single dose |
|
| Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3) |
| To evaluate the effect of AZD1656 on the pharmacodynamics of simvastatin by assessment of AUC(0-t) and Cmax of active 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitors. | Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3) |
| To evaluate the safety and tolerability of AZD1656 alone and in combination with simvastatin by assessments of adverse events, laboratory variables, electrocardiogram, blood pressure, pulse, results of physical examination, and weight. | At pre entry, during the study days, |
| D004700 | Endocrine System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |