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

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Diabetes

Diabetes Mellitus, Type 2

Treatments

Drug: placebo

Drug: liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01620463

NN2211-1326

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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