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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: BI 10773 (low)
Drug: Moxifloxacin
Drug: BI 10773 Placebo
Drug: BI 10773 (high)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: August 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 10773
single oral (high and low) dose per subject
Drug: BI 10773 (low)
single oral dose
Drug: BI 10773 (high)
single oral dose
Placebo Comparator: Placebo
2 single oral doses per subject
Drug: BI 10773 Placebo
2 times single dose
Active Comparator: Moxifloxacin
single oral dose per subject
Drug: Moxifloxacin
single oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

healthy female and male subjects

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195675

Locations
Germany
1245.16.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01195675     History of Changes
Other Study ID Numbers: 1245.16, 2010-018609-13
Study First Received: September 3, 2010
Last Updated: September 27, 2012
Health Authority: Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 23, 2014