Clinical trial NCT01517568: Metabolism and Excretion of Liraglutide in Healthy Male Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 7
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Profile and identity of the major metabolites of tritium labelled liraglutide in plasma, urine, and faeces
measure: Total recovery of tritium, [3H]-liraglutide and metabolites in urine and faeces
Secondary outcomes:
measure: Area under the curve
measure: Cmax, maximum concentration
measure: tmax, time to reach Cmax
measure: t½, terminal half-life
measure: The distribution of [3H]-liraglutide in whole blood versus plasma
measure: Adverse events
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Malm-Erjefalt M, Bjornsdottir 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 degradation by dipeptidyl peptidase IV and neutral endopeptidase. Drug Metab Dispos. 2010 Nov;38(11):1944-53. doi: 10.1124/dmd.110.034066. Epub 2010 Aug 13.