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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00839683
First received: February 5, 2009
Last updated: June 6, 2014
Last verified: June 2014

February 5, 2009
June 6, 2014
February 2009
March 2009   (final data collection date for primary outcome measure)
Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs [ Time Frame: 72 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00839683 on ClinicalTrials.gov Archive Site
  • To assess the safety and tolerability of dapagliflozin when administered alone, with valsartan, or with simvastatin in healthy subjects [ Time Frame: 15 timepoints ] [ Designated as safety issue: Yes ]
  • To assess the safety and tolerability of the combination of dapagliflozin with valsartan, and the combination of dapagliflozin with simvastatin in healthy subjects [ Time Frame: 15 timepoints ] [ Designated as safety issue: Yes ]
  • To assess the effect of dapagliflozin on the PK of simvastatin acid (active metabolite of simvastatin), when coadministered in healthy subjects [ Time Frame: 15 timepoints ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Type 2 Diabetes Mellitus
  • Drug: simvastatin
    Tablets, Oral, 20 mg, Single Dose
    Other Name: Zocor
  • Drug: Dapagliflozin
    Tablets, Oral, 20 mg, Single Dose
    Other Name: BMS-512148
  • Drug: simvastatin
    Oral, 40 mg, Single Dose
  • Drug: valsartan
    Tablets, Oral, 320 mg, Single Dose
    Other Name: Diovan
  • Active Comparator: simvastatin
    Intervention: Drug: simvastatin
  • Active Comparator: Dapagliflozin + simvastatin
    Interventions:
    • Drug: Dapagliflozin
    • Drug: simvastatin
  • Active Comparator: Dapagliflozin
    Intervention: Drug: Dapagliflozin
  • Active Comparator: valsartan
    Intervention: Drug: valsartan
  • Active Comparator: Dapagliflozin + valsartan
    Interventions:
    • Drug: Dapagliflozin
    • Drug: valsartan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00839683
MB102-036
No
Study Director, Bristol-Myers Squibb
AstraZeneca
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
AstraZeneca
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP