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
A Randomized, Open-Label, Parallel-group, Multiple-Dose 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
1 other identifier
interventional
42
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 type-2-diabetes-mellitus
Started Jul 2009
Shorter than P25 for phase_1 type-2-diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedFirst Posted
Study publicly available on registry
July 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedOctober 17, 2016
October 1, 2016
2 months
June 30, 2009
October 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs
24 hours post-dose on Day 8 and 15
Secondary Outcomes (2)
To assess the safety and tolerability of bumetanide and dapagliflozin following multiple oral doses of 1 mg bumetanide and 10 mg dapagliflozin, administered together, either simultaneously or after adaptation to either agent alone, in healthy subjects
during 14 days of dosing
Explore potential pharmacodynamic (serum/urine electrolytes) effects of bumetanide + dapagliflozin following multiple doses of 1 mg bumetanide + 10 mg dapagliflozin, administered together, either simultaneously or after adaptation to either agent alone
during 14 days of dosing
Study Arms (3)
Bumetanide
ACTIVE COMPARATORDapagliflozin
ACTIVE COMPARATORBumetanide + Dapagliflozin
ACTIVE COMPARATORInterventions
Tablets, Oral, 1 mg, Single Dose, 7 Days
Tablets, Oral, 10 mg. Single Dose, 7 Days
Eligibility Criteria
You may qualify 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 qualify 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Bristol-Myers Squibbcollaborator
Study Sites (1)
Ppd Development, Lp
Austin, Texas, 78744, United States
Related Publications (1)
Wilcox CS, Shen W, Boulton DW, Leslie BR, Griffen SC. Interaction Between the Sodium-Glucose-Linked Transporter 2 Inhibitor Dapagliflozin and the Loop Diuretic Bumetanide in Normal Human Subjects. J Am Heart Assoc. 2018 Feb 10;7(4):e007046. doi: 10.1161/JAHA.117.007046.
PMID: 29440005DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2009
First Posted
July 2, 2009
Study Start
July 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
October 17, 2016
Record last verified: 2016-10