A Phase 1 interventional study of ketoconazole and GSK189075 in Type 2 Diabetes Mellitus and Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-04.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Treatment
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.
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 22 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Also known as: ketoconazole
Plasma blood samples for GSK189075 at Day 1 Session 1, Days 5 & 6 Session 3
Time frame: 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.
Time frame: at Day 1 Session 1, Days 5 & 6 Session 3.
Adverse events: all visits
Time frame: all visits
ECG,labs: Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3
Time frame: Screening,Days -1 & 1 Session 1,Day 4 Session 2,Days 5-6 Session 3
Labs:followup
Time frame: followup
Urine: Day 1 Session 1,Days 5-6 Session 3
Time frame: 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
Time frame: Screening,Days -1 & 1 Session 1,Days 1-4 Session 2,Days 5-6 Session 3,followup
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline