Safety and Tolerability 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 to assess the safety and tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170 (liraglutide).

Official Title
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A Randomised, Double-blind, Placebo-controlled, Dose Escalation Trial of Single Doses of NNC90-1170 to Assess Tolerability, Pharmacokinetics, Pharmacodynamics and Absolute Bioavailability in Healthy Male Subjects

Conditions
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Diabetes, Healthy

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male subjects of any ethnic origin Written informed consent obtained. (The subject must give signed informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject) Good general health based on medical history, physical and laboratory examinations, incl. ECG (electrocardiogram) Body mass index within the range 20-27 kg/m^2, inclusive Exclusion Criteria: Any clinically significant abnormal laboratory test results or clinically significant abnormal ECG History of alcoholism or drug addiction; positive results in the plasma urine screens for illicit drug Alcohol intake within 48 hours of visit Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies History of significant drug allergy or drug hypersensitivity Smoke 5 cigarettes or more, or the equivalent per day and is unable to refrain from smoking during the 3 days prior to the dosing day and during the confinement period Subjects who drink more than 8 cups of tea/coffee per day

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC 90-1170 (liraglutide)<br> | Drug: liraglutide<br>* Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order<br>* Other names: NNC 90-1170;Drug: liraglutide<br>* Subjects receiving the dose level 5 mcg/kg s.c. will in addition receive, after a wash-out of at least 7 days, a single i.v. (into the vein) dose of 5 mcg/kg<br>* Other names: NNC 90-1170;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Administered s.c. After a wash-out of at least 7 days, a single i.v. (into the vein) dose is administered<br>Drug: placebo<br>* Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (area under the curve) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax, maximum concentration |  |  | 
| tmax, time to maximum concentration |  |  | 
| t½, terminal half-life |  |  |