A feasibility study for the use of 18F-Canagliflozin to quantify individual differences in target-site exposure in diabetes patients

niversity Medical Center Groningen0 个研究点目标入组 9 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

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•Pregnant women and women of child-bearing potential who are not using reliable contraception
•eGFR < 30 mL/min/1.73 m2
•Subjects on diuretics are allowed to participate but the dose should be stable for at least 4 weeks prior to screening
•Subjects already on a SGLT2 inhibitor are allowed to participate, but the drug should be interrupted 1 week prior to the first study day till the end of the second study day
•Subjects using a sulphonylurea.
•Established peripheral arterial disease
•Cardiovascular disease: myocardial infarction, angina pectoris, percutanous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I-IV) < 3 months before inclusion
•History of hypersensitivity to canagliflozin or another SGLT2 inhibitor
•Active malignancy
•Donation or loss of 400 ml or more of blood within 8 weeks prior to initial dosing
•History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
•Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:

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