Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy Subjects
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Keep this study
Lead
AstraZeneca
With
Bristol-Myers Squibb
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ \[height (m)\]²
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized and men, ages 18 to 45
You may not be if
WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
Any significant acute or chronic medical illness
Current or recent (within 3 months) gastrointestinal disease
Current smoker or recent (within 1 month) history of regular tobacco use
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
Abnormal urinalysis at screening
Glucosuria at screening
Abnormal liver functions tests (ALT, AST or total bilirubin \> 10 % ULN)
Presence of edema on physical exam
History of diabetes mellitus
History of heart failure
History of renal insufficiency
History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
Positive urine screen for drugs of abuse either at screening or before dosing
Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
History of allergy to SGLT2 inhibitors, bumetanide (or related compounds)
History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
Prior exposure to dapagliflozin within 3 months of Day -1
Exposure to any investigational drug or placebo within 4 weeks of Day -1
Use of any prescription drugs within 4 weeks or over-the-counter acid controllers within 2 weeks prior to study drug administration
Use of any other drugs, including over-the-counter medications within 1 week and herbal preparations, within 2 weeks prior to study drug administration
Use of an oral, injectable or implantable hormonal contraceptive agent within 3 months of study drug administration
Clareo Health | Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy Subjects
