Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Dapagliflozin (Drug); Glimepiride (Drug); Sitagliptin (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
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)
Clinical Details
Official title: Pharmacokinetic Drug Interaction Study of Dapagliflozin and Glimepiride or Sitagliptin in Healthy Subjects
Study design: Other, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
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 in healthy subjects
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
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
Locations and Contacts
Additional Information
Starting date: March 2009
Ending date: April 2009
Last updated: February 11, 2009
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