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Clinical Trial Details

Trial ID: L2767
Source ID: NCT00501462
Associated Drug: Gsk189075
Title: A Comparison Of Study Drug Blood Levels After One Dose Of GSK189075 In Subjects With Normal And Reduced Kidney Function
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Diabetes Mellitus, Type 2|Renal Insufficiency
Interventions: DRUG: GSK189075
Outcome Measures: Primary: 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 | Secondary: 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, 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
Sponsor/Collaborators: Sponsor: GlaxoSmithKline
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 29
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2007-07
Completion Date: 2008-03
Results First Posted:
Last Update Posted: 2012-03-19
Locations: GSK Investigational Site, Orlando, Florida, 32809, United States|GSK Investigational Site, Minneapolis, Minnesota, 55404, United States|GSK Investigational Site, Knoxville, Tennessee, 37920, United States|GSK Investigational Site, Austin, Texas, 78752, United States
URL: https://clinicaltrials.gov/show/NCT00501462

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress