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The purpose of this study is to determine whether AZD1656 will affect the pharmacokinetics (PK) of digoxin in type 2 diabetes mellitus (T2DM) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | twice daily Day 1 to Day 7; digoxin on day 4 |
|
| 2 | Placebo Comparator | twice daily Day 1 to Day 7; digoxin on day 4. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1656 | Drug | Oral tablet bd, step-wise increased dosage |
| |
| Digoxin |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the pharmacokinetics of digoxin after a single dose when administered alone and in combination with AZD1656 at steady state, by assessment of AUC and Cmax of digoxin | Serial PK blood samples will be taken on days 4-8 during the treatment periods |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the safety of AZD1656 in combination with digoxin by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables (including 7-point glucose), physical examination and adverse events. | Safety assessments will be monitored throughout the study, from screening visit until follow up visit. | |
| describe the pharmacokinetics of AZD1656 and its metabolite during concomitant digoxin administration by assessment of AUC(0-24), Cmax, Ctrough, tmax, t1/2 and CL/F (AZD1656 only). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stanko Skrtic | AstraZeneca | Study Director |
| Christoph Kapitza | Profil Institut für Stoffwechselforschung GmbH | Principal Investigator |
| Mirjana Kujacic | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chula Vista | California | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C576407 | AZD1656 |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Drug |
Oral tablet od on Day 4 |
|
|
| Placebo | Drug | Oral tablet bd, step-wise increased dosage |
|
| Serial PK blood samples will be taken on days 4-8 during the treatment periods |
| describe the pharmacokinetics of digoxin when administered alone or in combination with AZD1656 by assessment of tmax and t1/2. | Serial PK blood samples will be taken on days 4-8 during the treatment periods |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |