Healthy
Conditions
Keywords
QT, Healthy volunteers
Brief summary
The main purpose of this study is to examine the effect of dapagliflozin on electronic measures of heart beats in healthy males
Interventions
DRUGDapagliflozin
3 x 50 mg tablets, single oral dose
DRUGMoxifloxacin
Overencapsulated 400 mg capsule, single oral dose
DRUGPlacebo to match moxifloxacin and dapagliflozin
Overencapsulated 400 mg capsule, single oral dose
Sponsors
Bristol-Myers Squibb
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males age 18 to 45 years of age, who are not currently taking any medications * Normal screening results including a physical examination, laboratory tests, heart rate, blood pressure, and ECG (electronic measure of the heart)
Exclusion criteria
* No personal or family history of significant heart problems * No use of over the counter medications within 7 days of the study * No use of prescription medicaiton within 1 month of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Electronic measures of heart beats | ECGs (electronic measures of the heart) are taken at scheduled times during the 3 days after receiving each dose of study medication |
Secondary
| Measure | Time frame |
|---|---|
| Blood levels of dapagliflozin following single 20 mg and 150 mg doses in healthy volunteers | At scheduled times during the 3 day periods following dosing during each of the 4 study periods |
| Safety and tolerability of dapagliflozin | Screening through completion of the study |
Countries
United States
Outcome results
None listed