Effect of Liraglutide on Heart Frequency in Healthy Volunteers

What this study is testing ClinicalTrials.gov NCT01516255 ↗

Description as written by the study sponsor.

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.

Treatments tested

• liraglutide Drug

  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

• placebo Drug

  Injected subcutaneously. Subjects are randomly allocated to two treatment sequences

• moxifloxacin Drug

  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

• placebo Drug

  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

• electrocardiogram (ECG) Procedure

  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

• electrocardiogram (ECG) Procedure

  Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected