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Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00839683
Collaborator
Bristol-Myers Squibb (Industry)
24
Enrollment
1
Location
5
Arms
28
Duration (Days)
26.1
Patients Per Site Per Month

Study Details

Study Description

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 are coadministered in healthy subjects. Phase B - To assess the effect of valsartan on the PK of dapagliflozin and to determine the effect of dapagliflozin on the PK of valsartan, when valsartan and dapagliflozin are coadministered in healthy subjects

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Official Title:
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Mar 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: simvastatin

Drug: simvastatin
Tablets, Oral, 20 mg, Single Dose
Other Names:
  • Zocor

    		•
    Active Comparator: Dapagliflozin + simvastatin

    Drug: Dapagliflozin
    Tablets, Oral, 20 mg, Single Dose
    Other Names:
  • BMS-512148

    • Drug: simvastatin
    Oral, 40 mg, Single Dose
    Active Comparator: Dapagliflozin

    Drug: Dapagliflozin
    Tablets, Oral, 20 mg, Single Dose
    Other Names:
  • BMS-512148

    		•
    Active Comparator: valsartan

    Drug: valsartan
    Tablets, Oral, 320 mg, Single Dose
    Other Names:
  • Diovan

    		•
    Active Comparator: Dapagliflozin + valsartan

    Drug: Dapagliflozin
    Tablets, Oral, 20 mg, Single Dose
    Other Names:
  • BMS-512148

    • Drug: valsartan
    Tablets, Oral, 320 mg, Single Dose
    Other Names:
  • Diovan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs [72 hours post-dose]

    Secondary Outcome Measures

    1. To assess the safety and tolerability of dapagliflozin when administered alone, with valsartan, or with simvastatin in healthy subjects [15 timepoints]

    2. To assess the safety and tolerability of the combination of dapagliflozin with valsartan, and the combination of dapagliflozin with simvastatin in healthy subjects [15 timepoints]

    3. To assess the effect of dapagliflozin on the PK of simvastatin acid (active metabolite of simvastatin), when coadministered in healthy subjects [15 timepoints]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mds Pharma Services (Us) Inc. Neptune New Jersey United States 07753

    Sponsors and Collaborators

    • AstraZeneca
    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AstraZeneca
    ClinicalTrials.gov Identifier:
    NCT00839683
    Other Study ID Numbers:
    • MB102-036
    First Posted:
    Feb 9, 2009
    Last Update Posted:
    Oct 17, 2016
    Last Verified:
    Oct 1, 2016
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Dapagliflozin
    Valsartan
    Simvastatin

    Study Results

    No Results Posted as of Oct 17, 2016