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
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.
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 TolerabilityDapagliflozin and Dapagliflozin 3-O-glucuronide (Metabolite of Dapagliflozin) Concentrations to Characterize Dapagliflozin Pharmacokinetics
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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
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
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