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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2009-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bumetanide

Group Type ACTIVE_COMPARATOR

Bumetanide

Intervention Type DRUG

Tablets, Oral, 1 mg, Single Dose, 7 Days

Dapagliflozin

Group Type ACTIVE_COMPARATOR

Dapagliflozin

Intervention Type DRUG

Tablets, Oral, 10 mg. Single Dose, 7 Days

Bumetanide + Dapagliflozin

Group Type ACTIVE_COMPARATOR

Bumetanide

Intervention Type DRUG

Tablets, Oral, 1 mg, Single Dose, 7 Days

Dapagliflozin

Intervention Type DRUG

Tablets, Oral, 10 mg. Single Dose, 7 Days

Interventions

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Bumetanide

Tablets, Oral, 1 mg, Single Dose, 7 Days

Intervention Type DRUG

Dapagliflozin

Tablets, Oral, 10 mg. Single Dose, 7 Days

Intervention Type DRUG

Other Intervention Names

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Bumex BMS-512148

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes