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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01195675
First received: September 3, 2010
Last updated: July 25, 2014
Last verified: July 2014

September 3, 2010
July 25, 2014
August 2010
November 2010   (final data collection date for primary outcome measure)
  • Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing [ 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 ] [ Designated as safety issue: No ]

    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 [ 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 ] [ Designated as safety issue: No ]

    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.

The primary parameter of this study is the QTcN interval, where QTcN is the population heart rate corrected QT interval length, based on a parabolic model [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01195675 on ClinicalTrials.gov Archive Site
  • Empa 25 mg: Mean QTcN Change From Baseline Between 30 Minutes and 24 Hours After Dosing [ 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 ] [ Designated as safety issue: No ]

    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 [ 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 ] [ Designated as safety issue: No ]

    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 [ 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 ] [ Designated as safety issue: No ]

    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 [ 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 ] [ Designated as safety issue: No ]

    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 [ 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 ] [ Designated as safety issue: No ]

    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.

  • The mean of the QTcN changes from baseline of all electrocardiogramms taken from different time points after dosing [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Safety (Electrocardiogramm) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Safety (blood pressure) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Safety (laboratory values) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Tolerability (Assessment of tolerability by the investigator) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Time-matched Change From Placebo in QTcN Between 30 Minutes and 24 Hours After Dosing. [ 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 ] [ Designated as safety issue: No ]

    The time-matched change from placebo is defined per time point as the difference of the ECG measurement following administration of empa or moxifloxacin minus the average of the measurements obtained following the two administrations of placebo. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum mean value of all measurements.

    Results are presented for the greatest change, for empa 25mg the greatest change was seen at the 24 hour time point, for empa 200 mg and moxifloxacin the greatest change was seen at the 2.5 hour time point.

  • Placebo Corrected Change From Mean Baseline at Any Time Point Between 30 Minutes and 24 Hours After Dosings. [ 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 ] [ Designated as safety issue: No ]

    The placebo corrected change from mean baseline is defined per time point as the difference of the change from baseline for empa or moxifloxacin minus the average change from baseline obtained for the two administrations of placebo. The clinically relevant information (and endpoint resulting from ICH E14) is shown by the maximum mean value of all measurements.

    Results are presented for the greatest change, for empa 25mg the greatest change was seen at the 24 hour time point, for empa 200 mg and moxifloxacin the greatest change was seen at the 2.5 hour time point.

  • Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Blood Chemistry and Assessment of Tolerability by the Investigator [ Time Frame: Drug administration until beginning of next sequence/end of trial, up to 48 days ] [ Designated as safety issue: No ]
    Clinically relevant abnormalities for physical examination, vital signs, ECG, blood chemistry, haematology, urinanalysis and assessment of tolerability by the investigator. New abnormal findings or worsening of baseline conditions were reported as adverse events (AEs). Time frame for AE reporting includes the period of first drug administration until end of study. A more detailed definition of the used time frame and MedDRA Version can be found in the AE section.
Not Provided
 
Assessment of the Effect of Empagliflozin (BI 10773) as Single Dose on the QT Interval in Healthy Female and Male Subjects
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Healthy
  • Drug: BI 10773 (low)
    single oral dose
  • Drug: Moxifloxacin
    single oral dose
  • Drug: BI 10773 Placebo
    2 times single dose
  • Drug: BI 10773 (high)
    single oral dose
  • Experimental: BI 10773
    single oral (high and low) dose per subject
    Interventions:
    • Drug: BI 10773 (low)
    • Drug: BI 10773 (high)
  • Placebo Comparator: Placebo
    2 single oral doses per subject
    Intervention: Drug: BI 10773 Placebo
  • Active Comparator: Moxifloxacin
    single oral dose per subject
    Intervention: Drug: Moxifloxacin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
November 2010   (final data collection date for primary outcome measure)

Inclusion criteria:

healthy female and male subjects

Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01195675
1245.16, 2010-018609-13
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP