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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00501462 |
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.
Condition | Intervention | Phase |
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Type 2 Diabetes Mellitus Renal Insufficiency |
Drug: GSK189075 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | An Evaluation of the Pharmacokinetics of a Single Oral Dose of GSK189075 in Patients With Varying Degrees of Renal Insufficiency Compared to Volunteers With Normal Renal Function |
Enrollment: | 29 |
Study Start Date: | July 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Additional Exclusion Criteria for Subjects with Renal Insufficiency
United States, Florida | |
GSK Investigational Site | |
Orlando, Florida, United States, 32809 | |
United States, Minnesota | |
GSK Investigational Site | |
Minneapolis, Minnesota, United States, 55404 | |
United States, Tennessee | |
GSK Investigational Site | |
Knoxville, Tennessee, United States, 37920 | |
United States, Texas | |
GSK Investigational Site | |
Austin, Texas, United States, 78752 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | KG2105253 |
Study First Received: | July 13, 2007 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00501462 |
Health Authority: | United States: Food and Drug Administration |
Type 2 Diabetes Mellitus renal insufficiency |
Renal Insufficiency Metabolic Diseases Urologic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Kidney Diseases Metabolic disorder Glucose Metabolism Disorders |