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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: placebo; Drug: liraglutide

• Registration Number: NCT01620463
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2003-03
• Study Completion: 2003-03
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-13
• Study First Posted: 2012-06-15
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-23
• Last Update Posted: 2017-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
NNC 90-1170	liraglutide	-

Primary Outcome Measures

Name	Time	Method
Body weight
Vital signs (Blood pressure)
Vital signs (Pulse rate)
ECG (ElectroCardioGram)
Adverse events

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan