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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 10773 (low); Drug: BI 10773 Placebo; Drug: Moxifloxacin; Drug: BI 10773 (high)

• Registration Number: NCT01195675
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-06
• Primary Completion: 2010-11
• Results First Submitted: 2014-05-16
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-25
• Last Update Submitted: 2014-07-25
• Results First Posted: 2014-07-28
• Last Update Posted: 2014-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BI 10773	BI 10773 (low)	single oral (high and low) dose per subject
Placebo	BI 10773 Placebo	2 single oral doses per subject
BI 10773	BI 10773 (high)	single oral (high and low) dose per subject
Moxifloxacin	Moxifloxacin	single oral dose per subject

Primary Outcome Measures

Name	Time	Method
Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing	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	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.
Empa 200mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing	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	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.

Secondary Outcome Measures

Name	Time	Method
Empa 25 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing	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 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.
Empa 200 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing	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 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.
Mean QTcN Change From Baseline Between 2 and 4 Hours After Dosing	60 minutes (min), 50min and 40 min before the first dose and 2 hour (h), 2.5h, 3h and 4h after the first dose	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.
Empa 25mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings	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	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.
Empa 200mg: Change From Mean Baseline in QTcN at Each Time Point Between 30 Minutes and 24 Hours After Dosings	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	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.

Trial Locations

Locations (1)

1245.16.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany