Safety and Tolerability of Liraglutide in Healthy Japanese Volunteers

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Liraglutide

Criteria

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