Metabolism and Excretion of Liraglutide in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: liraglutide [3H]

• Registration Number: NCT01517568
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Study First Submitted: 2012-01-21
• Study First Submitted QC: 2012-01-21
• Study First Posted: 2012-01-25
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liraglutide	liraglutide [3H]	-

Primary Outcome Measures

Name	Time	Method
Profile and identity of the major metabolites of tritium labelled liraglutide in plasma, urine, and faeces
Total recovery of tritium, [3H]-liraglutide and metabolites in urine and faeces

Secondary Outcome Measures

Name	Time	Method
tmax, time to reach Cmax
Area under the curve
t½, terminal half-life
The distribution of [3H]-liraglutide in whole blood versus plasma
Cmax, maximum concentration
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇳🇱 Groningen, Netherlands