Clincosm LogoSign in Get a demo

Metabolism and Excretion of Liraglutide in Healthy Male Volunteers

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT01517568
Collaborator
(none)
7
Enrollment
1
Location
1
Arm
30
Duration (Days)
7.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: liraglutide [3H]
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
7 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2006
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
Dec 1, 2006

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Profile and identity of the major metabolites of tritium labelled liraglutide in plasma, urine, and faeces []

    2. Total recovery of tritium, [3H]-liraglutide and metabolites in urine and faeces []

    Secondary Outcome Measures

    1. Area under the curve []

    2. Cmax, maximum concentration []

    3. tmax, time to reach Cmax []

    4. t½, terminal half-life []

    5. The distribution of [3H]-liraglutide in whole blood versus plasma []

    6. Adverse events []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novo Nordisk Investigational Site Groningen Netherlands 9728 NZ

    Sponsors and Collaborators

    • Novo Nordisk A/S

    Investigators

    • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Novo Nordisk A/S
    ClinicalTrials.gov Identifier:
    NCT01517568
    Other Study ID Numbers:
    • NN2211-1699
    • 2006-002293-22
    First Posted:
    Jan 25, 2012
    Last Update Posted:
    Jan 26, 2017
    Last Verified:
    Jan 1, 2017
    Additional relevant MeSH terms:
    Liraglutide

    Study Results

    No Results Posted as of Jan 26, 2017