Metabolism and Excretion of Liraglutide in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01517568
First received: January 21, 2012
Last updated: NA
Last verified: January 2012
History: No changes posted
  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: [3H]-liraglutide
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 [ Designated as safety issue: No ]
  • Total recovery of tritium, [3H]-liraglutide and metabolites in urine and faeces [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the curve [ Designated as safety issue: No ]
  • Cmax, maximum concentration [ Designated as safety issue: No ]
  • tmax, time to reach Cmax [ Designated as safety issue: No ]
  • t½, terminal half-life [ Designated as safety issue: No ]
  • The distribution of [3H]-liraglutide in whole blood versus plasma [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

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: [3H]-liraglutide
A single dose of 0.75 mg will be given as a subcutaneous injection

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517568

Locations
Netherlands
Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Milan Zdravkovic, MD, PhD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01517568     History of Changes
Other Study ID Numbers: NN2211-1699, 2006-002293-22
Study First Received: January 21, 2012
Last Updated: January 21, 2012
Health Authority: Netherlands: Dutch Health Care Inspectorate

Additional relevant MeSH terms:
Liraglutide
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 21, 2014