Status:
COMPLETED
Metabolism and Excretion of Liraglutide in Healthy Male Volunteers
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
MALE
30-65 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2006
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01517568
Start Date
November 1 2006
End Date
December 1 2006
Last Update
January 26 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Groningen, Netherlands, 9728 NZ