Metabolism and Excretion of Liraglutide in Healthy Male Volunteers

January 25, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9728 NZ
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liraglutide
Drug: liraglutide [3H]
A single dose of 0.75 mg will be given as a subcutaneous injection
Other Names:
  • [3H]-liraglutide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

January 21, 2012

First Submitted That Met QC Criteria

January 21, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-1699
  • 2006-002293-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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