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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
single 250 mg dose of drug
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
Knoxville, Tennessee, United States
GSK Investigational Site
Austin, Texas, United States
drug & metabolite plasma levels
Time frame: at 0.25, 0.50, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, & 24 hours after dosing
urine levels of Glucose & electrolytes, Drug & metabolites
Time frame: at 0-6, 6-12 & 12-24 hours after dosing
ECG, labs, vital signs, adverse events
Time frame: each visit
Plasma protein binding of GSK189074 and GSK279782
Time frame: 2 hr
GSK189074 and GSK279782 in 24 hour urine collection and corresponding renal clearance CLr.
Time frame: 24 hr
urine glucose excreted.
Time frame: 6, 12, 24 hours
Urinary creatinine clearance (CLcr).
Time frame: 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).
Time frame: 1, 2, 4, 12, 24 hours
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