This trial is conducted in the United States of America (USA). The aim of this trial is to investigate if liraglutide effects the QTc interval. Moxifloxacin (Avelox®) is administered as positive control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
0.6 mg daily for 7 days followed by 1.2 mg daily for 7 days followed by 1.8 mg daily for 7 days. Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
Following the double-blinded period and a wash-out period of 7 days, subjects are re-randomised to an open-label, parallel period where a single dose of 400 mg moxifloxacin (tablets) is administered as positive control
Novo Nordisk Investigational Site
Fargo, North Dakota, United States
Maximum time-matched mean difference between the baseline subtracted QTci intervals
QTc at liraglutide tmax (time to reach maximum concentration)
Percentage subjects with QTc at least 450, 480 and 500 milliseconds
Moxifloxacin maximum time-matched mean change QTc and QTci
Cmax, maximum concentration of liraglutide
tmax, time to reach Cmax of liraglutide
Vitals signs: Blood pressure
Vital signs: Pulse
Serial electrocardiography
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Following the double-blinded period and a wash-out period of 7 days, subjects are re-randomised to an open-label, parallel period where single dose of oral placebo is administered
24 hours serial ECG is collected before initial dose of 0.6 mg liraglutide, on the last dosing day of 1.2 mg liraglutide and on the last dosing day of 1.8 mg liraglutide
Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected