Comparison of Liraglutide Injected at Three Different Injection Sites in 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 pharmacokinetic profile of liraglutide between administrations in the thigh versus the abdomen and between administrations in the upper arm versus the abdomen.

Official Title
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A Randomised, Open-label, Single Centre, Three Period Cross-over Trial in Healthy Subjects Comparing the Pharmacokinetic Profiles After Single Dose Administration of Liraglutide at Three Different Injection Sites

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: Healthy 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 (Body Mass Index): 18.5-27.5 kg/m^2, both inclusive Exclusion Criteria: Known or suspected allergy to trial product(s) or related products Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods as required by local law or practice The receipt of any investigational drug within 3 months prior to this trial 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 and/or active hepatitis C Positive human immunodeficiency virus (HIV) antibodies Use of any prescription or non-prescription medication, except for paracetamol and vitamins History of alcoholism or drug abuse during the last 12 months. Smoking 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 Blood donation within the last 3 months Plasma donation within the last month

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdomen<br> | Drug: liraglutide<br>* Single dose of 0.60 mg administered subcutaneously in three different injection sites on three separate dosing visits<br>|
| Experimental: Thigh<br> | Drug: liraglutide<br>* Single dose of 0.60 mg administered subcutaneously in three different injection sites on three separate dosing visits<br>|
| Experimental: Upper arm<br> | Drug: liraglutide<br>* Single dose of 0.60 mg administered subcutaneously in three different injection sites on three separate dosing visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Curve (AUC) of liraglutide for each injection site |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC |  |  | 
| Cmax, maximum concentration |  |  | 
| tmax, time to maximum concentration |  |  | 
| t½, terminal half-life |  |  | 
| Terminal elimination rate constant |  |  | 
| Relative Bioavailability |  |  | 
| Adverse events |  |  |