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This is an explorative study and the scientific question to be investigated is if the biliary excretion of AZD0837 and its metabolites AR-H069927XX and AR-H067637XX are affected by co-administration with ketoconazole
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator | AZD0837 + Ketoconazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD0837 | Drug | Oral solution, dosing through the Loc-I-Gut catheter, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of AZD0837, AR-H069927XX, and AR-H067637XX in bile and biliary clearance of AZD0837, AR-H069927XX, and AR-H067637XX. | Frequent sampling through a Loc-I-Gut catheter for up to 3 hours post dose. |
| Measure | Description | Time Frame |
|---|---|---|
| PK variables of AZD0837, AR-H069927XX, and AR-H067637XX. | Frequent sampling during 24 hours. | |
| Adverse events, physical examination, safety laboratory variables, blood pressure, pulse and electrocardiography. | Some of the safety variables will be followed at each visit, some less frequent. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Knutson, MD, PhD | Inst för Kirurgiska VetenskaperUppsala Universitet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Uppsala | Sweden |
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| ID | Term |
|---|---|
| C551586 | AZD 0837 |
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ketoconazole |
| Drug |
tablets, orally, once daily for 3 days |
|
| ketoconazole | Drug | dissolved tablets, dosing through the Loc-I-Gut catheter, single dose |
|
| Pharmacogenetics | One sampling during the study. |