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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Drug: liraglutide; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 1000005
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: 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
Experimental: NNC 90-1170	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; Other Names: NNC 90-1170

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Adverse events
Body weight
Vital signs (Blood pressure)
Vital signs (Pulse rate)
ECG (ElectroCardioGram)

Secondary Outcome Measures

Outcome Measure
Area under the plasma NNC 90-1170 curve
Maximum plasma NNC 90-1170 concentration, Cmax
Time to maximum plasma NNC 90-1170 concentration, tmax
Terminal elimination half-life, t1/2
24-hour glucose profile in serum
24-hour insulin profile in serum
24-hour glucagon profile in plasma

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• 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. Endocrinology and Diabetology 2007; 24 (6): 95-104

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (Actual): March 1, 2003
• Study Completion (Actual): March 1, 2003

Study Registration Dates

• First Submitted: June 13, 2012
• First Submitted That Met QC Criteria: June 13, 2012
• First Posted (Estimate): June 15, 2012

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: NN2211-1326