A Phase 1 interventional study of AZD1656 and simvastatin in Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-11-07.
Sponsored by AstraZeneca · Phase 1 and Interventional
To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 44 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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Exclusion Criteria:
AZD1656
Drug: AZD1656
Simvastatin
Drug: simvastatin
AZD1656 + simvastatin
Drug: AZD1656 · Drug: simvastatin
Oral tablet, BID dose
Oral tablet, single dose
To evaluate the effect of AZD1656 on the steady state pharmacokinetics of simvastatin (including simvastatin acid) and vice versa by assessment of AUC(0-24) and Cmax.
Time frame: Frequent blood samples for PK analysis will be drawn during 24 hours post morning dose on day 4 in each treatment period (1-3)
To evaluate the effect of AZD1656 on the steady state pharmacokinetics of simvastatin and simvastatin acid and vice versa by assessment of tmax, t1/2 and CL/F (only for AZD1656)
Time frame: Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3)
To evaluate the steady state pharmacokinetics of the AZD1656 metabolite when AZD1656 is administered with and without simvastatin, by assessment of AUC(0-24), Cmax and tmax.
Time frame: Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3)
To evaluate the effect of AZD1656 on the pharmacodynamics of simvastatin by assessment of AUC(0-t) and Cmax of active 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitors.
Time frame: Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3)
To evaluate the safety and tolerability of AZD1656 alone and in combination with simvastatin by assessments of adverse events, laboratory variables, electrocardiogram, blood pressure, pulse, results of physical examination, and weight.
Time frame: At pre entry, during the study days,
This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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