The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c) interval more than placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
single oral dose
single oral dose
2 times single dose
1245.16.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing
Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline electrocardiogram (ECGs) obtained pre-dose at each visit, for empa 25mg. Note, the treatment means presented are actually adjusted means.
Time frame: 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose
Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing
Mean QTcN (heart rate-corrected QT interval, using a study population-based approach) from the ECGs obtained between 1h to 4h following drug administration minus the mean QTcN from the baseline ECGs obtained pre-dose at each visit, for empa 200mg. Note, the treatment means presented are actually adjusted means.
Time frame: 60 minutes (min), 50min and 40 min before the first dose and 1 hour (h), 1.5h, 2h, 2.5h, 3h and 4h after the first dose
Empa 25 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing
Mean changes from baseline in QTcN from all ECGs taken between 30 minutes and 24 hours after dosings, for empa 25 mg. Note, presented means are actually adjusted means.
Time frame: 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose
Empa 200 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing
Mean changes from baseline in QTcN from all ECGs taken between 30 minutes and 24 hours after dosings, for empa 200 mg. Note, presented means are actually adjusted means.
Time frame: 60 minutes (min), 50min and 40 min before the first dose and 30min, 1 hour (h), 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose
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single oral dose
Mean QTcN Change From Baseline Between 2 and 4 Hours After Dosing
Mean changes from baseline in QTcN from all ECGs taken between 2 hours and 4 hours after dosings Note, the means presented are actually adjusted means.
Time frame: 60 minutes (min), 50min and 40 min before the first dose and 2 hour (h), 2.5h, 3h and 4h after the first dose
Empa 25mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings
Change from mean baseline in QTcN at each time point between 30 minutes and 24 hours after dosings for empa 25mg. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum upper confidence limit value over time. For this outcome results are presented for the 24 hour timepoint as this was when the maximum value was seen. Note, the presented means are actually adjusted means.
Time frame: 60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose
Empa 200mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings
Change from mean baseline in QTcN at each time point between 30 minutes and 24 hours after dosings for empa 200mg. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum upper confidence limit value over time. For this outcome results are presented for the 2.5 hour timepoint as this was when the maximum value was seen. Note, the presented means are actually adjusted means.
Time frame: 60 minutes (min), 50min and 40 min before the first dose and 0.5 hour (h), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h and 24h after the first dose