Effect of Liraglutide on Heart Frequency in Healthy Volunteers

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Fluoroquinolones; Liraglutide; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Criteria

Inclusion Criteria:

• Healthy

• Fasting plasma glucose within normal limits (80-100 mg/dl)

• BMI (Body Mass Index): 20.0-29.0 kg/m^2 (inclusive)

• Heart rate within the range of 50-90 beats per minute (inclusive)

• Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data

Exclusion Criteria:

• Any clinically significant disease history, in the opinion of the investigator, of systemic or organ disease

• Any clinically significant disease history, in the opinion of the investigator, of cardiovascular disease

• Clinically significant abnormalities on any pre-study clinical examination or any abnormal laboratory measurements during screening

• A family history of sudden cardiac death at age less than 50 years old

• T-wave abnormalities

• Individual or familial history of long QT Syndrome

• Positive results on Screening for Hepatitis B surface antigen, Hepatitis C antibody or HIV (human immunodeficiency virus) antibody

• Positive results on the urine drug and alcohol screen

• Any regular use of prescription or nonprescription drugs or vitamins and herbal/nutritional supplements that cannot be stopped at screening

• Any strenuous exercise (as judged by the investigator) from 4 days prior to randomisation and during the entire trial period

• Blood donation, trauma or surgery with blood loss exceeding 500 ml within the last 2 months prior to dosing

• Subject is a smoker, occasional smoker or has a history of smoking (or use of any tobacco) within the last 3 months

• Excessive use of methylxanthine-containing beverages (more than 8 cups/day of coffee, tea, soda or chocolate)

• Females who are pregnant, breastfeeding, intend to become pregnant within the next 3 months, or who are judged to be using inadequate contraceptive measures

• A history (within the last 2 years) of drug or alcohol abuse