Safety and Tolerability of Liraglutide in Healthy Male Volunteers

Healthy Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled, Dose Escalation Trial of Single Doses of NNC90-1170 to Assess Tolerability, Pharmacokinetics, Pharmacodynamics and Absolute Bioavailability in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507272
• Other study ID #: NN2211-1149
• Status: Completed
• Phase: Phase 1
• First received: January 5, 2012
• Last updated: January 23, 2017
• Start date: March 1999
• Est. completion date: December 1999

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 1999
• Est. primary completion date: December 1999
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• liraglutide
Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order
• liraglutide
Subjects receiving the dose level 5 mcg/kg s.c. will in addition receive, after a wash-out of at least 7 days, a single i.v. (into the vein) dose of 5 mcg/kg
• placebo
Administered s.c. After a wash-out of at least 7 days, a single i.v. (into the vein) dose is administered
• placebo
Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order

Locations

Country	Name	City	State
United Kingdom	Novo Nordisk Investigational Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Agersø H, Vicini P. Pharmacodynamics of NN2211, a novel long acting GLP-1 derivative. Eur J Pharm Sci. 2003 Jun;19(2-3):141-50. — View Citation

Elbrønd B, Jakobsen G, Larsen S, Agersø H, Jensen LB, Rolan P, Sturis J, Hatorp V, Zdravkovic M. Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose of NN2211, a long-acting glucagon-like peptide 1 derivative, in healthy male sub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC (area under the curve)
Secondary	Cmax, maximum concentration
Secondary	tmax, time to maximum concentration
Secondary	t½, terminal half-life

External Links

•   Clinical Trials at Novo Nordisk