Status:
COMPLETED
Comparison of Liraglutide Inhaled Into the Lungs Compared to Liraglutide Injected Under the Skin in Healthy Male Volunteers
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this trial is to determine the relative bioavailability of NNC 90-1170 (liraglutide) when inhaled compared to NNC 90-1170 when injected under the skin.
Eligibility Criteria
Inclusion
- No clinically important abnormal physical findings
- No clinically relevant abnormalities in the results of laboratory screening evaluation
- Normal (or abnormal but not clinically significant) ECG (electrocardiogram)
- Normal (or abnormal but not clinically significant) blood pressure and heart rate
- Body Mass Index (BMI) between 20-30 kg/m\^2 or outwith range but not clinically significant
- Non-smoker
- Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) at least 85% of predicted normal for age, gender and height
- FVC ratio at least 75% of predicted normal for age, gender and height
Exclusion
- A clinically significant illness or infection requiring treatment within the last two months
- Any infection involving the respiratory system or adverse event that may, in the opinion of the principal investigator, interfere with blood glucose homeostasis
- Subjects with first and/or second degree relative(s) with diabetes mellitus
- Donation or loss of greater than 500 ml of blood in the period 0-12 weeks before trial entry
- Alcohol use in excess of 28 units of alcohol per week. A unit of alcohol is equivalent to half a pint of average strength beer, a glass (125 ml) of wine or a pub measure (25 ml) of spirits, sherry or port
- Current addiction to alcohol or substances of abuse
- Females
- Presence of hepatitis B surface antigen, hepatitis C antibody or HIV (human immunodeficiency virus) 1 or 2 antibodies
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2001
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01511159
Start Date
October 1 2001
End Date
December 1 2001
Last Update
March 26 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tranent, United Kingdom, EH33 2NE