Metabolism and Excretion of Liraglutide in Healthy Male Volunteers

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is conducted in Europe. The aim of this trial is characterise the metabolic profile of liraglutide in plasma, urine, and faeces after a single injection of [3H]-liraglutide.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

• Good general health as judged by the Investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, and blood and urinary laboratory assessments

• BMI (Boday Mass Index) of 20.0-27.0 kg/m^2, both inclusive

Exclusion Criteria:

• History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator

• Impaired renal function

• Active hepatitis B or active hepatitis C

• Positive human immunodeficiency virus (HIV) antibodies

• Any clinically significant abnormal ECG, as judged by the Investigator

• Any clinically significant abnormal laboratory test results, as judged by the Investigator

• Acute infection or inflammation or other illness that may influence the metabolism and excretion pattern of the trial product, as judged by the Investigator

• Known or suspected allergy to trial product(s) or related products

• History of alcoholism or drug abuse or positive results in alcohol and drug screens

• Smoking of more than 5 cigarettes per day

• Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the Investigator

• Excessive consumption of a diet deviating from a normal diet, as judged by the Investigator