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Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00842556
Collaborator
Bristol-Myers Squibb (Industry)
18
Enrollment
1
Location
5
Arms
2
Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the effect of glimepiride on the PK of dapagliflozin and the effect of dapagliflozin on the PK of glimepiride, when co-administered in healthy subjects (Phase A) and to assess the effect of sitagliptin on the PK of dapagliflozin and the effect of dapagliflozin on the PK of sitagliptin, when co-administered in healthy subjects (Phase B)

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

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

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dapagliflozin

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

    		•
    Active Comparator: Glimepiride

    Drug: Glimepiride
    Tablets, Oral, 4 mg, Single Dose
    Other Names:
  • Amaryl

    		•
    Active Comparator: Dapagliflozin + Glimepiride

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

    • Drug: Glimepiride
    Tablets, Oral, 4 mg, Single Dose
    Other Names:
  • Amaryl

    		•
    Active Comparator: Sitagliptin

    Drug: Sitagliptin
    Tablets, Oral, 100 mg, Single Dose
    Other Names:
  • Januvia

    		•
    Active Comparator: Dapagliflozin + Sitagliptin

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

    • Drug: Sitagliptin
    Tablets, Oral, 100 mg, Single Dose
    Other Names:
  • Januvia

    		•

    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 after dosing]

    Secondary Outcome Measures

    1. To assess the safety and tolerability in healthy subjects [15 time points up to 72 hours after dosing]

    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:

    • WOCBP 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 liver functions tests (ALT, AST or total bilirubin > 10% above ULN)

    • History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months

    • History of allergy to SGLT@ inhibitors, DPP$ inhibitors or sulfonylurea or related compounds

    • Prior exposure to dapagliflozin, sitagliptin and glimepiride within 3 months of Day -1

    • History of recurrent (defined as 3 occurrences per year) or recent vulvovaginal mycotic infections

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ppd Development Austin Texas United States 78744

    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:
    NCT00842556
    Other Study ID Numbers:
    • MB102-037
    First Posted:
    Feb 12, 2009
    Last Update Posted:
    Oct 17, 2016
    Last Verified:
    Oct 1, 2016
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Sitagliptin Phosphate
    Dapagliflozin
    Glimepiride

    Study Results

    No Results Posted as of Oct 17, 2016