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The purpose of this research study is to evaluate the effect of several daily doses of ketoconazole (a medication used to treat fungal infections like athlete's foot) on a single dose of GSK189075 (an experimental diabetes drug), and also to evaluate the safety and tolerability of GSK189075 in healthy volunteers. The study will see whether ketoconazole causes GSK189075 to stay in your bloodstream for a longer period of time. It will also examine whether GSK189075 causes any changes in the amount of glucose you have in your urine.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketoconazole | Drug | |||
| GSK189075 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma blood samples for GSK189075 at Day 1 Session 1, Days 5 & 6 Session 3 | at Day 1 Session 1, Days 5 & 6 Session 3 urine collections for volume | |
| urine collections for volume, glucose, & creatinine at Day 1 Session 1, Days 5 & 6 Session 3. | at Day 1 Session 1, Days 5 & 6 Session 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events: all visits | all visits | |
| ECG,labs: Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3 | Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Columbus | Ohio | 43212 | 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 |
|---|---|
| D007654 | Ketoconazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Labs:followup |
| followup |
| Urine: Day 1 Session 1,Days 5-6 Session 3 | Day 1 Session 1,Days 5-6 Session 3 |
| Vitals: Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup | Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup |
| D004700 | Endocrine System Diseases |