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

Completed · Phase 1

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT01135446

Run by

AstraZeneca

People needed

35

Starts

2010-05-01

Expected to finish

2010-06-01

Last updated by the study team

2016-10-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy men and women
• WOCBP who are using acceptable method of contraception
• Women who are not nursing

You may not qualify if…

• 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

Where it is running

• Ppd Development, Lp — Austin, Texas, United States

Full record on ClinicalTrials.gov

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