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: September 27, 2012
Last verified: September 2012

September 3, 2010
September 27, 2012
August 2010
November 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01195675 on ClinicalTrials.gov Archive Site
  • The mean of the QTcN changes from baseline of all electrocardiograms taken from different time points after dosing [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Safety (Electrocardiogram) [ 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 ]
  • 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 ]
Not Provided
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
September 2012

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