Safety and Tolerability of Liraglutide in Healthy Male Volunteers

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Healthy

Diabetes

Treatments

Drug: placebo

Drug: liraglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT01507272

NN2211-1149

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to assess the safety and tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170 (liraglutide).

Enrollment

34 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male subjects of any ethnic origin
Written informed consent obtained. (The subject must give signed informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject)
Good general health based on medical history, physical and laboratory examinations, incl. ECG (electrocardiogram)
Body mass index within the range 20-27 kg/m^2, inclusive

Exclusion criteria

Any clinically significant abnormal laboratory test results or clinically significant abnormal ECG
History of alcoholism or drug addiction; positive results in the plasma urine screens for illicit drug
Alcohol intake within 48 hours of visit
Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies
History of significant drug allergy or drug hypersensitivity
Smoke 5 cigarettes or more, or the equivalent per day and is unable to refrain from smoking during the 3 days prior to the dosing day and during the confinement period
Subjects who drink more than 8 cups of tea/coffee per day