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Metabolism and Excretion of Liraglutide in Healthy Male Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01517568
First Posted: January 25, 2012
Last Update Posted: January 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
January 21, 2012
January 25, 2012
January 26, 2017
November 2006
December 2006   (Final data collection date for primary 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
Same as current
Complete list of historical versions of study NCT01517568 on ClinicalTrials.gov Archive Site
  • 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
  • Adverse events
Same as current
Not Provided
Not Provided
 
Metabolism and Excretion of Liraglutide in Healthy Male Volunteers
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Diabetes
  • Healthy
Drug: liraglutide [3H]
A single dose of 0.75 mg will be given as a subcutaneous injection
Other Name: [3H]-liraglutide
Experimental: Liraglutide
Intervention: Drug: liraglutide [3H]
Malm-Erjefält M, Bjørnsdottir 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
December 2006
December 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
30 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01517568
NN2211-1699
2006-002293-22 ( EudraCT Number )
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP