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OpenTrials
Completed

NCT Number: NCT01517568

Metabolism and Excretion of Liraglutide in Healthy Male Volunteers

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.

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Key information

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Groningen, 9728 NZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide [3H]

Drug

A single dose of 0.75 mg will be given as a subcutaneous injection

Other names: [3H]-liraglutide

Primary outcomes

  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

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Jan 25, 2012
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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