Diabetes, Healthy
Conditions
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.
Interventions
DRUGliraglutide [3H]
A single dose of 0.75 mg will be given as a subcutaneous injection
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Profile and identity of the major metabolites of tritium labelled liraglutide in plasma, urine, and faeces | — |
| Total recovery of tritium, [3H]-liraglutide and metabolites in urine and faeces | — |
Secondary
| Measure | Time frame |
|---|---|
| tmax, time to reach Cmax | — |
| t½, terminal half-life | — |
| Area under the curve | — |
| Adverse events | — |
| The distribution of [3H]-liraglutide in whole blood versus plasma | — |
| Cmax, maximum concentration | — |
Countries
Netherlands
Outcome results
None listed