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Completed

NCT Number: NCT01516255

Effect of Liraglutide on Heart Frequency in Healthy Volunteers

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Fargo, North Dakota, 58104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Maximum time-matched mean difference between the baseline subtracted QTci intervals

Secondary outcomes

  1. QTc at liraglutide tmax (time to reach maximum concentration)

  2. Percentage subjects with QTc at least 450, 480 and 500 milliseconds

  3. Moxifloxacin maximum time-matched mean change QTc and QTci

  4. Cmax, maximum concentration of liraglutide

  5. tmax, time to reach Cmax of liraglutide

  6. Vitals signs: Blood pressure

  7. Vital signs: Pulse

  8. Serial electrocardiography

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jan 24, 2012
Registry last updated
Jan 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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