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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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes Mellitus

Intervention: Bumetanide (Drug); Dapagliflozin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs

Secondary outcome:

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Ppd Development, Lp, Austin, Texas 78744, United States
Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: July 2009
Last updated: March 20, 2015

Page last updated: August 23, 2015

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