Clinical Trials/NCT00839683

NCT00839683

Completed

Phase 1

Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects

AstraZeneca1 site in 1 country24 target enrollmentFebruary 2009

ConditionsType 2 Diabetes Mellitus

Interventionsvalsartan Dapagliflozin simvastatin

Drugssimvastatin Dapagliflozin valsartan

Overview

Phase: Phase 1
Intervention: valsartan
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Enrollment: 24
Locations: 1
Primary Endpoint: Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Phase A - To assess the effect of simvastatin on the pharmacokinetics (PK) of dapagliflozin and to determine the effect of dapagliflozin on the PK of simvastatin, when simvastatin and dapagliflozin are coadministered in healthy subjects. Phase B - To assess the effect of valsartan on the PK of dapagliflozin and to determine the effect of dapagliflozin on the PK of valsartan, when valsartan and dapagliflozin are coadministered in healthy subjects

Registry

clinicaltrials.gov

Start Date

February 2009

End Date

March 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
•Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/\[height (m)\]2

Exclusion Criteria

•Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product
•Abnormal urinalysis at screening (repeat urinalysis may be allowed for positive hematuria in women)
•Glucosuria at screening
•Abnormal liver functions tests (ALT, AST or total bilirubin \> 10% above ULN)
•Presence of edema on physical exam
•History of diabetes mellitus
•History of heart failure
•History of renal insufficiency
•History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
•History of recurrent (defined as 3 occurences per year) or recent vulvovaginal mycotic infections

Arms & Interventions

valsartan

Intervention: valsartan

Dapagliflozin + valsartan

Intervention: Dapagliflozin

Dapagliflozin

Intervention: Dapagliflozin

simvastatin

Intervention: simvastatin

Dapagliflozin + simvastatin

Intervention: Dapagliflozin

Dapagliflozin + simvastatin

Intervention: simvastatin

Dapagliflozin + valsartan

Intervention: valsartan

Outcomes

Primary Outcomes

Exposure to the investigational drug will be measured to compare with and without the co-administration of other drugs

Time Frame: 72 hours post-dose

Secondary Outcomes

To assess the safety and tolerability of dapagliflozin when administered alone, with valsartan, or with simvastatin in healthy subjects(15 timepoints)
To assess the safety and tolerability of the combination of dapagliflozin with valsartan, and the combination of dapagliflozin with simvastatin in healthy subjects(15 timepoints)
To assess the effect of dapagliflozin on the PK of simvastatin acid (active metabolite of simvastatin), when coadministered in healthy subjects(15 timepoints)