Metabolism and Excretion of Liraglutide in Healthy Male Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Centre, Open Label Trial Investigating the Metabolites in Plasma, Urine and Faeces After a Single Subcutaneous Dose of [3H]-Liraglutide to Healthy Subjects

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: liraglutide [3H]


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide<br> | Drug: liraglutide [3H]<br>* A single dose of 0.75 mg will be given as a subcutaneous injection<br>* Other names: [3H]-liraglutide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve |  |  | 
| Cmax, maximum concentration |  |  | 
| tmax, time to reach Cmax |  |  | 
| t½, terminal half-life |  |  | 
| The distribution of [3H]-liraglutide in whole blood versus plasma |  |  | 
| Adverse events |  |  |