Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Healthy Japanese Volunteers

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Randomised, Double-blind, Single-centre, Placebo-controlled, Ascending Single s.c. Dose, Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 90-1170 in Healthy Japanese Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620463
• Other study ID #: NN2211-1326
• Status: Completed
• Phase: Phase 1
• First received: June 13, 2012
• Last updated: January 23, 2017
• Start date: December 2002
• Est. completion date: March 2003

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 NNC 90-1170 (liraglutide) in healthy Japanese male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) between 18 and 27 kg/m^2, inclusive

Exclusion Criteria:

• Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator or Sub-Investigator

• Presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous, as judged by the Investigator

• Blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90-150 mmHg systolic or 40-90 mmHg diastolic

• Heart rate in supine position at the screening, after resting for 5 min, outside the range 40-100 beats/min

• Alcohol intake within 48 hours prior to the screening

• Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive

• Clinically relevant abnormal history or physical findings at the screening, which could interfere with the objectives of the study or the safety of the subject's participation, as judged by the Investigator

• History of significant allergy or hypersensitivity

• Known or suspected allergy to trial product or related products

• History of drug or alcohol abuse

• Smoking 10 cigarettes or more, or the equivalent, per day and is unwilling to refrain from smoking during 3 days prior to dosing and during the confinement period

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
Single dose administered subcutaneously at four different dose levels: 2.5, 5.0, 10.0 and 15.0 mcg/kg. Following completion of each dose group, an evaluation will be performed to allow progression to the next dose group
• placebo
Single dose administered subcutaneously at four different dose levels: 2.5, 5.0, 10.0 and 15.0 mcg/kg. Following completion of each dose group, an evaluation will be performed to allow progression to the next dose group

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	Body weight
Primary	Vital signs (Blood pressure)
Primary	Vital signs (Pulse rate)
Primary	ECG (ElectroCardioGram)
Primary	Adverse events
Secondary	Area under the plasma NNC 90-1170 curve
Secondary	Maximum plasma NNC 90-1170 concentration, Cmax
Secondary	Time to maximum plasma NNC 90-1170 concentration, tmax
Secondary	Terminal elimination half-life, t1/2
Secondary	24-hour glucose profile in serum
Secondary	24-hour insulin profile in serum
Secondary	24-hour glucagon profile in plasma

External Links

•   Clinical Trials at Novo Nordisk