Status:
COMPLETED
Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Healthy Japanese subjects
- BMI (Body Mass Index) between 18.0-27.0 kg/m\^2 inclusive
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01515592
Start Date
January 1 2006
End Date
April 1 2006
Last Update
January 25 2017
Active Locations (1)
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1
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005