Comparison of Liraglutide Inhaled Into the Lungs Compared to Liraglutide Injected Under the Skin 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 to determine the relative bioavailability of NNC 90-1170 (liraglutide) when inhaled compared to NNC 90-1170 when injected under the skin.

Official Title
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A Single-Centre, Open-Label, Five-Period Crossover Trial In Healthy Male Volunteers Investigating the Relative Bioavailability of NNC 90-1170 By Pulmonary Administration Compared To A Subcutaneous Injection

Conditions
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Diabetes, Healthy

Intervention / Treatment
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* Drug: liraglutide
* Drug: placebo
* Drug: liraglutide
* Drug: liraglutide
* Drug: insulin human
* Drug: insulin human
* Drug: liraglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No clinically important abnormal physical findings No clinically relevant abnormalities in the results of laboratory screening evaluation Normal (or abnormal but not clinically significant) ECG (electrocardiogram) Normal (or abnormal but not clinically significant) blood pressure and heart rate Body Mass Index (BMI) between 20-30 kg/m^2 or outwith range but not clinically significant Non-smoker Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) at least 85% of predicted normal for age, gender and height FVC ratio at least 75% of predicted normal for age, gender and height Exclusion Criteria: A clinically significant illness or infection requiring treatment within the last two months Any infection involving the respiratory system or adverse event that may, in the opinion of the principal investigator, interfere with blood glucose homeostasis Subjects with first and/or second degree relative(s) with diabetes mellitus Donation or loss of greater than 500 ml of blood in the period 0-12 weeks before trial entry Alcohol use in excess of 28 units of alcohol per week. A unit of alcohol is equivalent to half a pint of average strength beer, a glass (125 ml) of wine or a pub measure (25 ml) of spirits, sherry or port Current addiction to alcohol or substances of abuse Females Presence of hepatitis B surface antigen, hepatitis C antibody or HIV (human immunodeficiency virus) 1 or 2 antibodies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC 90-1170, initial dose<br> | Drug: liraglutide<br>* Single dose of 6 mcg/kg by inhalation. Progression to open-label trial part will be based on safety data<br>Drug: placebo<br>* Single dose by inhalation. Progression to open-label trial part will be based on safety data<br>|
| Experimental: NNC 90-1170<br> | Drug: liraglutide<br>* Single dose of 12 mcg/kg by inhalation. Subjects receive treatment in random order<br>Drug: liraglutide<br>* Single dose 6 mcg/kg injected subcutaneously. Subjects receive treatment in random order<br>|
| Active Comparator: Insulin<br> | Drug: insulin human<br>* Single dose 0.4 IU/kg by inhalation. Subjects receive treatment in random order<br>Drug: insulin human<br>* Single dose 0.08 IU/kg injected subcutaneously. Subjects receive treatment in random order<br>|
| Experimental: NNC 90-1170, final dose<br> | Drug: liraglutide<br>* 24 mcg/kg by inhalation. Progression to dose level will be based on safety evaluation<br>* Other names: NNC 90-1170;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of the areas under the plasma NN 90-1170 curves |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum concentration (Cmax) |  |  | 
| The time to maximum concentration (tmax) |  |  | 
| Mean residence time (MRT) |  |  | 
| Area under the curve |  |  | 
| Terminal rate constant |  |  | 
| Adverse events |  |  |