NCT01516255CompletedPhase 1
A Thorough QTc Evaluation of the Effect of Liraglutide on Cardiac Repolarization in Healthy Volunteers: A Randomized, Double-blind, Placebo-controlled, Two Period Crossover Study Followed by Open-label Moxifloxacin (Positive Control) Administration
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Maximum time-matched mean difference between the baseline subtracted QTci intervals
Study Overview
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 control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Arms & Interventions
Open-label / moxifloxacin
Active Comparator
Intervention: electrocardiogram (ECG) (Procedure)
Double-blind / liraglutide
Experimental
Intervention: placebo (Drug)
Double-blind / liraglutide
Experimental
Intervention: liraglutide (Drug)
Double-blind / liraglutide
Experimental
Intervention: electrocardiogram (ECG) (Procedure)
Double-blind / placebo
Placebo Comparator
Intervention: liraglutide (Drug)
Double-blind / placebo
Placebo Comparator
Intervention: placebo (Drug)
Double-blind / placebo
Placebo Comparator
Intervention: electrocardiogram (ECG) (Procedure)
Open-label / moxifloxacin
Active Comparator
Intervention: moxifloxacin (Drug)
Open-label / placebo
Placebo Comparator
Intervention: placebo (Drug)
Open-label / placebo
Placebo Comparator
Intervention: electrocardiogram (ECG) (Procedure)
Outcomes
Primary Outcomes
Maximum time-matched mean difference between the baseline subtracted QTci intervals
Secondary Outcomes
- tmax, time to reach Cmax of liraglutide
- QTc at liraglutide tmax (time to reach maximum concentration)
- Percentage subjects with QTc at least 450, 480 and 500 milliseconds
- Cmax, maximum concentration of liraglutide
- Vitals signs: Blood pressure
- Serial electrocardiography
- Moxifloxacin maximum time-matched mean change QTc and QTci
- Vital signs: Pulse
Investigators
Study Sites (1)
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