Status:
COMPLETED
Effect of Liraglutide on Heart Frequency in Healthy Volunteers
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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 contr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01516255
Start Date
July 1 2006
End Date
November 1 2006
Last Update
January 25 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novo Nordisk Investigational Site
Fargo, North Dakota, United States, 58104