Comparison of the Effect of Liraglutide in Young Versus Elderly Healthy 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 to compare the exposure of liraglutide in young versus elderly healthy subjects.

Official Title
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An Open Label, Single Dose Trial With Two Groups Comparing the Pharmacokinetics of Liraglutide in Young Versus Elderly Healthy Subjects of Both Sexes

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: liraglutide


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 Age, young subjects: age 18-45 years (both incl.) Age, elderly subjects: age at least 65 years Body Mass Index (BMI) 18-30 kg/m^2 (both incl.) Blood pressure, young: Diastolic 50-90 mmHg, systolic 90-140 mmHg Blood pressure, elderly: Diastolic 50-95 mmHg, systolic 92-160 mmHg Exclusion Criteria: History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease, or other major disorders that could interfere with the objectives of the trial, as judged by the investigator Impaired renal function Any clinically significant abnormal ECG (electrocardiogram) Active hepatitis B and/or active hepatitis C Positive HIV (human immunodeficiency virus) antibodies Febrile illness within 5 days prior to first administration of liraglutide History of alcoholism or drug abuse during the last 12 months Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Elderly<br> | Drug: liraglutide<br>* A single dose of 1 mg administered subcutaneously (under the skin)<br>|
| Experimental: Young<br> | Drug: liraglutide<br>* A single dose of 1 mg administered subcutaneously (under the skin)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the liraglutide plasma concentration time curve (AUC 0-t) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the liraglutide plasma concentration time curve (AUC 0-infinity) |  |  | 
| Cmax, maximum liraglutide plasma concentration |  |  | 
| tmax, time to reach Cmax |  |  | 
| t½, terminal plasma elimination half-life |  |  | 
| Adverse events |  |  |