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Trial · Interventional

CompletedPhase 1Registry data

Metabolism and Excretion of Liraglutide in Healthy Male Volunteers

NCTNCT01517568 (opens ClinicalTrials.gov in a new tab)Other idNN2211-1699Other id2006-002293-22

Overview

Status
Completed
Phase
Phase 1
Enrollment
7 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Not randomized · Open label (no masking)
Countries
1 country

Netherlands

Start
Nov 2006
Primary completion
Dec 2006
Completion
Dec 2006
First posted
25 Jan 2012 (estimated)
Last update posted
26 Jan 2017 (estimated)
Conditions
Diabetes · Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20062007
  1. Ph 1

    Metabolism and Excretion of Liraglutide in Healthy Male Volunteers

    NCT01517568

    Nov 2006 to Dec 2006

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutide [3H]Drug

Arms1

  • Experimental

    Liraglutide

Primary outcomes2

Outcomes the sponsor listed as primary.

  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 outcomes(6)
  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2010

7 results

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.

Malm-Erjefält et al. 2010Drug metabolism and disposition: the biological fate of chemicalscited by 146

PMID 20709939DOI 10.1124/dmd.110.034066PUB-20709939

Full text at the publisher7 results

Eligibility

Who could join, as posted.

Sex
Male
Age
from 30 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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