Status:
COMPLETED
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin in Healthy Subjects
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Healthy men and women
- WOCBP who are using acceptable method of contraception
- Women who are not nursing
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01135446
Start Date
May 1 2010
End Date
June 1 2010
Last Update
October 17 2016
Active Locations (1)
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1
Ppd Development, Lp
Austin, Texas, United States, 78744