Status:
COMPLETED
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin 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
Phase A - To assess the effect of simvastatin on the pharmacokinetics (PK) of dapagliflozin and to determine the effect of dapagliflozin on the PK of simvastatin, when simvastatin and dapagliflozin ar...
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
Exclusion
- Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product
- Abnormal urinalysis at screening (repeat urinalysis may be allowed for positive hematuria in women)
- Glucosuria at screening
- Abnormal liver functions tests (ALT, AST or total bilirubin \> 10% above 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
- History of recurrent (defined as 3 occurences per year) or recent vulvovaginal mycotic infections
- Positive urine screen for drugs of abuse either at screening or before dosing
- Positive blood screen for hepatitis C antibody, hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
- History of allergy to SGLT2 inhibitors or related compounds
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
- History of allergy or intolerance to valsartan or simvastatin (or related compounds)
- Prior exposure to dapagliflozin, valsartan or simvastatin 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 any study drug administration
- Use of any other drugs, including over-the counter medications within 1 week and herbal preparations within 2 weeks prior to admission to the study facility
- Use of an oral, injectable or implantable hormonal contraceptive agent within 3 months of Day -1
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00839683
Start Date
February 1 2009
End Date
March 1 2009
Last Update
October 17 2016
Active Locations (1)
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1
Mds Pharma Services (Us) Inc.
Neptune City, New Jersey, United States, 07753