Phase 1
N=30
Assessment of the Effect of Empagliflozin (BI 10773) as Single Dose on the QT Interval in Healthy Female and Male Subjects
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01195675 ↗Enrolled (actual)
30
Serious AEs
0.9%
Results posted
Jul 2014
Primary outcome: Primary: Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing — 3.68; 4.27 ms
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 10773 (low) (Drug); Moxifloxacin (Drug); BI 10773 Placebo (Drug); BI 10773 (high) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing |
3.68; 4.27 | — |
| PRIMARY Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing |
3.67; 3.44 | — |
| SECONDARY Empa 25 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing |
0.71; 1.37 | — |
| SECONDARY Empa 200 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing |
0.68; 0.53 | — |
| SECONDARY Mean QTcN Change From Baseline Between 2 and 4 Hours After Dosing |
3.53; 15.96 | <0.0001 sig |
| SECONDARY Empa 25mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings |
-4.46; -2.30 | — |
| SECONDARY Empa 200mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings |
3.05; 4.64 | — |
Summary
The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c) interval more than placebo
Eligibility Criteria
Inclusion criteria
healthy female and male subjects
Data sourced from ClinicalTrials.gov (NCT01195675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.