Metabolism and Excretion of Liraglutide in Healthy Male Volunteers

Healthy Clinical Trial

Official title:

A Single-Centre, Open Label Trial Investigating the Metabolites in Plasma, Urine and Faeces After a Single Subcutaneous Dose of [3H]-Liraglutide to Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517568
• Other study ID #: NN2211-1699
• Secondary ID: 2006-002293-22
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2012
• Last updated: January 25, 2017
• Start date: November 2006
• Est. completion date: December 2006

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 characterise the metabolic profile of liraglutide in plasma, urine, and faeces after a single injection of [3H]-liraglutide.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Good general health as judged by the Investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, and blood and urinary laboratory assessments

• BMI (Boday Mass Index) of 20.0-27.0 kg/m^2, both inclusive

Exclusion Criteria:

• History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator

• Impaired renal function

• Active hepatitis B or active hepatitis C

• Positive human immunodeficiency virus (HIV) antibodies

• Any clinically significant abnormal ECG, as judged by the Investigator

• Any clinically significant abnormal laboratory test results, as judged by the Investigator

• Acute infection or inflammation or other illness that may influence the metabolism and excretion pattern of the trial product, as judged by the Investigator

• Known or suspected allergy to trial product(s) or related products

• History of alcoholism or drug abuse or positive results in alcohol and drug screens

• Smoking of more than 5 cigarettes per day

• Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the Investigator

• Excessive consumption of a diet deviating from a normal diet, as judged by the Investigator

Related Conditions & MeSH terms

• Diabetes
• Healthy

Intervention

Drug:
• liraglutide [3H]
A single dose of 0.75 mg will be given as a subcutaneous injection

Locations

Country	Name	City	State
Netherlands	Novo Nordisk Investigational Site	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Malm-Erjefält M, Bjørnsdottir I, Vanggaard J, Helleberg H, Larsen U, Oosterhuis B, van Lier JJ, Zdravkovic M, Olsen AK. Metabolism and excretion of the once-daily human glucagon-like peptide-1 analog liraglutide in healthy male subjects and its in vitro d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Profile and identity of the major metabolites of tritium labelled liraglutide in plasma, urine, and faeces
Primary	Total recovery of tritium, [3H]-liraglutide and metabolites in urine and faeces
Secondary	Area under the curve
Secondary	Cmax, maximum concentration
Secondary	tmax, time to reach Cmax
Secondary	t½, terminal half-life
Secondary	The distribution of [3H]-liraglutide in whole blood versus plasma
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk