Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers

Study Overview
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Brief Summary
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This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of 20 µg/kg and 25 µg/kg liraglutide in healthy Japanese male subjects.

Official Title
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A Randomised, Double-blind Within Dose Group, Single Centre, Placebo-controlled, Dose Escalation, Multiple s.c. Dose Study to Assess the Safety and Tolerability of Liraglutide 20 ug/kg and 25 ug/kg in Healthy Japanese Male Subjects

Conditions
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Diabetes, Diabetes Mellitus, Type 2

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Japanese subjects BMI (Body Mass Index) between 18.0-27.0 kg/m^2 inclusive Exclusion Criteria: Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal ECG (electrocardiogram) findings at the screening Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive History of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders History of significant allergy or hypersensitivity Known or suspected allergy to trial product or related products History of drug or alcohol abuse The subjects who smoke more than 15 cigarettes, or the equivalent, per day and is unwilling to refrain from smoking whenever required for the trial procedure

Ages Eligible for Study
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Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 15 mcg/kg<br> | Drug: liraglutide<br>* One daily subcutaneous dose for 5 weeks. Dose is weekly incremented with 5 mcg/kg<br>Drug: placebo<br>* Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1<br>|
| Experimental: 20 mcg/kg<br> | Drug: liraglutide<br>* One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg the third week, and finally 20 mcg for 2 weeks<br>Drug: placebo<br>* Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1<br>|
| Experimental: 25 mcg/kg<br> | Drug: liraglutide<br>* One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg for 3 weeks<br>Drug: placebo<br>* Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 
| Body weight |  |  | 
| Antibody against liraglutide |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma liraglutide concentration curve |  |  | 
| Cmax, maximum concentration |  |  | 
| tmax, time to reach Cmax |  |  | 
| Terminal elimination rate constant |  |  | 
| t½, terminal elimination half-life |  |  | 
| 24-hour profiles of plasma glucose |  |  | 
| 24-hour profiles of serum insulin |  |  |