Assessment of the Effect of Empagliflozin (BI 10773) as Single Dose on the QT Interval in Healthy Female and Male Subjects

Study Overview
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Brief Summary
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The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c) interval more than placebo

Official Title
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Assessment of the Effect of 25 mg and 200 mg of BI 10773 as Single Dose on the QT Interval in Healthy Female and Male Subjects. A Randomised, Placebo Controlled, Double-blind, Five-period Crossover Phase-I-study With Moxifloxacin as Positive Control

Conditions
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Healthy

Intervention / Treatment
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* Drug: BI 10773 (low)
* Drug: Moxifloxacin
* Drug: BI 10773 Placebo
* Drug: BI 10773 (high)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: healthy female and male subjects

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BI 10773<br>single oral (high and low) dose per subject | Drug: BI 10773 (low)<br>* single oral dose<br>Drug: BI 10773 (high)<br>* single oral dose<br>|
| Placebo Comparator: Placebo<br>2 single oral doses per subject | Drug: BI 10773 Placebo<br>* 2 times single dose<br>|
| Active Comparator: Moxifloxacin<br>single oral dose per subject | Drug: Moxifloxacin<br>* single oral dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 | 
| 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. | 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. | 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. | 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 |