An Open-label, Randomised, Two-period Crossover Study to Assess the Effect of Dapagliflozin on Percent Inhibition of Glucose Re-absorption When Administered Once a Day (10 mg OD) Versus Twice a Day (5 mg BID) in Healthy Male and Female Volunteers

AstraZeneca1 site in 1 country16 target enrollmentFebruary 2010

ConditionsHealthy Volunteers

InterventionsDapagliflozin

DrugsDapagliflozin

Overview

Phase: Phase 1
Intervention: Dapagliflozin
Conditions: Healthy Volunteers
Sponsor: AstraZeneca
Enrollment: 16
Locations: 1
Primary Endpoint: Calculation of derivation of pharmacokinetic variables
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the study is to assess the effect of dapagliflozin on the amount of glucose in the blood and urine when dapagliflozin is administered once a day (10 mg) versus twice a day (5 mg every 12 hours) after five days of dosing.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

April 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female healthy volunteers must be post-menopausal (cessation of menses \>1year, be surgically sterile (documented) or have undergone hysterectomy) or be sexually abstinent from enrolment until follow-up examination
•Have normal physical exam, vital signs ECG findings, and laboratory values

Exclusion Criteria

•Use of prescription medication for a chronic or acute medical condition within 3 weeks of randomization
•History or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs as determined by the Investigator
•Previous participation in an AstraZeneca (AZ) or Bristol-Myers Squibb (BMS) dapagliflozin study

Arms & Interventions

1

Intervention: Dapagliflozin

2

Intervention: Dapagliflozin

Outcomes

Primary Outcomes

Calculation of derivation of pharmacokinetic variables

Time Frame: Up to 14 blood samples will be obtained on day 1 (with the closest interval between samples being 15 minutes), one sample on days 3 and 4, and up to 21 samples on day 5

Secondary Outcomes

Calculation of derivation of pharmacodynamic variables (inhibition of plasma glucose re-absorption, 24 hour urine glucose excretion, inhibition of rate of gut glucose absorption by measuring plasma glucose, insulin and GIP).(plasma glucose will be drawn on Day 5, creatinine will be drawn at pre-dose of Day 4 and of Day 5, glucose and insulin will be drawn on Day 5 , Day 5 for GIP, urine will be collected on Day 5 in 4-hour intervals)
To examine the safety and tolerability of the combination of dapagliflozin and metformin(Adverse events and laboratory variables assessed throughout both 5-day treatment periods, and a follow-up visit 5-10 days later)