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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetes

Intervention: dapagliflozin (Drug); dapagliflozin (Drug); dapagliflozin (Drug); dapagliflozin (Drug); dapagliflozin (Drug); dapagliflozin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect

Secondary outcome:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Dapagliflozin and Dapagliflozin 3-O-glucuronide (Metabolite of Dapagliflozin) Concentrations to Characterize Dapagliflozin Pharmacokinetics


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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

Locations and Contacts

Ppd Development, Lp, Austin, Texas 78744, United States
Additional Information

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Starting date: May 2010
Last updated: March 20, 2015

Page last updated: August 23, 2015

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