Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to examine the effect of dapagliflozin on electronic measures of heart beats in healthy males
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 mg single dose of dapagliflozin | Experimental | 20 mg dapagliflozin |
|
| 150 mg single dose of dapagliflozin2 | Experimental | 150 mg dapagliflozin |
|
| 400 mg single dose of moxifloxacin | Active Comparator | Moxifloxacin |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | 3 x 50 mg tablets, single oral dose |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Glenn Carlson, MD | AstraZeneca | Study Director |
| Ronald Goldwater, MD | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baltimore | Maryland | United States |
Not provided
| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dapagliflozin | Drug | 2 x 10 mg capsules, single oral dose |
|
| Moxifloxacin | Drug | Overencapsulated 400 mg capsule, single oral dose |
|
|
| Placebo to match moxifloxacin and dapagliflozin | Drug | Overencapsulated 400 mg capsule, single oral dose |
|
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |