Safety and Tolerability of Liraglutide in Healthy Japanese Volunteers

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620476
• Other study ID #: NN2211-1551
• Status: Completed
• Phase: Phase 1
• First received: June 13, 2012
• Last updated: January 24, 2017
• Start date: September 2003
• Est. completion date: March 2004

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• liraglutide
5 mcg/kg for 21 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data
• liraglutide
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
• liraglutide
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
• placebo
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Kageyama S, Hirao K, Shimizu A, Matsumura Y, Zdravkovic M, Rasmussen MF, Irie S. Tolerability, pharmacokinetics, and pharmacodynamics of liraglutide, long-acting human GLP-1 analogue - Phase 1 studies in Japanese healthy subjects with type 2 diabetes. End

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma liraglutide curve
Secondary	Cmax, maximum plasma liraglutide concentration
Secondary	tmax, time to reach Cmax
Secondary	Terminal phase elimination rate-constant
Secondary	t½, terminal elimination half life
Secondary	24-hour profiles of serum insulin
Secondary	24-hour profiles of serum glucose
Secondary	24-hour profiles of plasma glucagon
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk