Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Dapagliflozin

Criteria

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