Safety and Tolerability of Liraglutide in Healthy Male Volunteers
- Registration Number
- NCT01507272
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 34
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NNC 90-1170 (liraglutide) liraglutide - Placebo placebo -
- Primary Outcome Measures
Name Time Method AUC (area under the curve)
- Secondary Outcome Measures
Name Time Method Cmax, maximum concentration tmax, time to maximum concentration t½, terminal half-life
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧Manchester, United Kingdom