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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Moxifloxacin; Drug: BI 10773 (high); Drug: BI 10773 Placebo; Drug: BI 10773 (low)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01195675

2010-018609-13 (EudraCT Number)

1245.16

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

healthy female and male subjects

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

BI 10773

Experimental group

Description:

single oral (high and low) dose per subject

Treatment:

Drug: BI 10773 (low)

Drug: BI 10773 (high)

Placebo

Placebo Comparator group

Description:

2 single oral doses per subject

Treatment:

Drug: BI 10773 Placebo

Moxifloxacin

Active Comparator group

Description:

single oral dose per subject

Treatment:

Drug: Moxifloxacin