Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
To assess the potential pharmacokinetic (PK) interactions of bumetanide and dapagliflozin following multiple doses of 1 mg bumetanide and 10 mg dapagliflozin in healthy subjects
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00930865
Start Date
July 1 2009
End Date
September 1 2009
Last Update
October 17 2016
Active Locations (1)
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1
Ppd Development, Lp
Austin, Texas, United States, 78744