Type 2 Diabetes
Conditions
Brief summary
The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single oral doses of 0.001 mg to 2.5 mg dapagliflozin in healthy subjects.
Interventions
DRUGdapagliflozin
Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days
Sponsors
Bristol-Myers Squibb
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy men and women * WOCBP who are using acceptable method of contraception * Women who are not nursing
Exclusion criteria
* History of GI disease * Any GI surgery that could impact study drug absorption * Glucosuria at screening or Day -2 * Abnormal liver function tests (ALT, AST or total bilirubin \> 10% above ULN) * History of current or recurrent UTI * History of Diabetes Mellitus * History of chronic or recurrent vulvovaginal mycotic infections * Estimated creatinine clearance (ClCr) \< 80 mL/min using Cockroft-Gault formula * History of allergy to SGLT2 inhibitors or related compounds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect | 24 hours after dosing |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 24 hours after dosing |
| Dapagliflozin and Dapagliflozin 3-O-glucuronide (Metabolite of Dapagliflozin) Concentrations to Characterize Dapagliflozin Pharmacokinetics | 2 days after dosing |
Countries
United States
Outcome results
None listed