Metabolism and Excretion of Liraglutide in Healthy Male Volunteers

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Treatments

Drug: liraglutide [3H]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01517568

2006-002293-22 (EudraCT Number)

NN2211-1699

Details and patient eligibility

About

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.

Enrollment

7 estimated patients

Sex

Male

Ages

30 to 65 years old

Volunteers

No Healthy Volunteers

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