Safety and Tolerability of Liraglutide in Healthy Japanese 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 liraglutide in healthy Japanese male subjects.

Official Title
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A Randomised, Double-blind, Single-centre, Placebo-controlled, 21-day Multiple s.c. Doses, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide (NNC 90-1170) in Healthy Japanese Male Subjects

Conditions
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Diabetes, Healthy

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 Body mass index (BMI) between 18 and 27 kg/m^2 inclusive Exclusion Criteria: Any clinical laboratory values deviated from the reference range at the laboratory 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 Smokes more than 15 cigarettes, or the equivalent, per day andis 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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Accepts Healthy Volunteers

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: 5 mcg/kg<br> | Drug: liraglutide<br>* 5 mcg/kg for 21 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data<br>Drug: placebo<br>* Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1<br>|
| Experimental: 10 mcg/kg<br> | Drug: liraglutide<br>* 5 mcg/kg for 7 days followed by 10 mcg/kg for 14 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data<br>Drug: placebo<br>* Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1<br>|
| Experimental: 15 mcg/kg<br> | Drug: liraglutide<br>* 5 mcg/kg for 7 days followed by 10 mcg/kg for 7 days followed by 15 mcg/kg for 7 days. Injected subcutaneously once daily<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 |
| --- | --- | --- |
| Area under the plasma liraglutide curve |  |  | 

Secondary Outcome Measures

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