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
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
7
1 country
1
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2006
Actual (reported)Study Completion
December 2006
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2006
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
December 2006
Actual (reported)December 2006
Actual (reported)January 21, 2012
Actual (reported)January 25, 2012
Actual (reported)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
Area under the curve
Cmax, maximum concentration
tmax, time to reach Cmax
t½, terminal half-life
The distribution of [3H]-liraglutide in whole blood versus plasma
A single dose of 0.75 mg will be given as a subcutaneous injection
Novo Nordisk Investigational Site
Groningen, 9728 NZ, Netherlands
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.
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
First Submitted
January 21, 2012
First Posted
January 25, 2012
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2006
Actual (reported)Contact the study team to confirm eligibility.
Study Completion
December 2006
Actual (reported)Last Updated
January 26, 2017
Record last verified: 2017-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: