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This is an open-label study that will measure blood levels of different parts of a drug called GKS189075. People participating in this study will receive a single dose of 250mg GSK189075 by mouth. About 20 people with mild to moderate decrease in renal (kidney) function will be asked to participate in this study. They will be compared to about 20 healthy participants who are close to the same age and body size. People participating in this study will stay at a clinical research unit beginning 2 days before they receive their single dose of GSK189075 and will remain there until approximately one day after receiving the study drug. During this study urine will be collected beginning the day before receiving study drug until the day after, just prior to leaving the clinical research unit. Blood samples will also be collected at various times beginning immediately before until 24 hours after receiving the study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild renal impairmnent | Other |
| |
| moderate renal impairment | Other |
| |
| Normal renal function | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK189075 | Drug | single 250 mg dose of drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| drug & metabolite plasma levels | at 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, & 24 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| urine levels of Glucose & electrolytes, Drug & metabolites | at 0-6, 6-12 & 12-24 hours after dosing | |
| ECG, labs, vital signs, adverse events | each visit | |
| Plasma protein binding of GSK189074 and GSK279782 |
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Inclusion Criteria:
Exclusion Criteria:
Additional Exclusion Criteria for Subjects with Renal Insufficiency
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Orlando | Florida | 32809 | United States | ||
| GSK Investigational Site |
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| 2 hr |
| GSK189074 and GSK279782 in 24 hour urine collection and corresponding renal clearance CLr. | 24 hr |
| urine glucose excreted. | 6, 12, 24 hours |
| Urinary creatinine clearance (CLcr). | 6, 12, 24 hours |
| Safety and tolerability parameters, including AEs and clinically relevant changes in vital signs (heart rate and blood pressure), ECGs, urine electrolytes, and clinical laboratory assessments (clinical chemistry, hematology, and urinalysis). | 1, 2, 4, 12, 24 hours |
| Minneapolis |
| Minnesota |
| 55404 |
| United States |
| GSK Investigational Site | Knoxville | Tennessee | 37920 | United States |
| GSK Investigational Site | Austin | Texas | 78752 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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