NCT01620476
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- placebo
- Conditions
- Diabetes
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Area under the plasma liraglutide curve
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
15 mcg/kg
Intervention: placebo
5 mcg/kg
Intervention: liraglutide
5 mcg/kg
Intervention: placebo
10 mcg/kg
Intervention: liraglutide
10 mcg/kg
Intervention: placebo
15 mcg/kg
Intervention: liraglutide
Outcomes
Primary Outcomes
Area under the plasma liraglutide curve
Secondary Outcomes
- Cmax, maximum plasma liraglutide concentration
- tmax, time to reach Cmax
- Terminal phase elimination rate-constant
- 24-hour profiles of serum glucose
- t½, terminal elimination half life
- 24-hour profiles of serum insulin
- 24-hour profiles of plasma glucagon
- Adverse events
Study Sites (1)
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