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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
  Purpose
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 Intervention Phase
Diabetes Healthy Drug: liraglutide [3H] Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 7
Study Start Date: November 2006
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide Drug: liraglutide [3H]
A single dose of 0.75 mg will be given as a subcutaneous injection
Other Name: [3H]-liraglutide

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517568


Locations
Netherlands
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
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01517568     History of Changes
Other Study ID Numbers: NN2211-1699
2006-002293-22 ( EudraCT Number )
First Submitted: January 21, 2012
First Posted: January 25, 2012
Last Update Posted: January 26, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists