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OpenTrials
Completed

NCT Number: NCT01507337

Comparison of the Effect of Liraglutide in Young Versus Elderly Healthy Volunteers

This trial is conducted in Europe. The aim of this trial is to compare the exposure of liraglutide in young versus elderly healthy subjects.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

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
  • Age, young subjects: age 18-45 years (both incl.)
  • Age, elderly subjects: age at least 65 years
  • Body Mass Index (BMI) 18-30 kg/m^2 (both incl.)
  • Blood pressure, young: Diastolic 50-90 mmHg, systolic 90-140 mmHg
  • Blood pressure, elderly: Diastolic 50-95 mmHg, systolic 92-160 mmHg

Exclusion criteria

  • History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease, or other major disorders that could interfere with the objectives of the trial, as judged by the investigator
  • Impaired renal function
  • Any clinically significant abnormal ECG (electrocardiogram)
  • Active hepatitis B and/or active hepatitis C
  • Positive HIV (human immunodeficiency virus) antibodies
  • Febrile illness within 5 days prior to first administration of liraglutide
  • History of alcoholism or drug abuse during the last 12 months
  • Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products
  • Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator

Treatment and study plan

liraglutide

Drug

A single dose of 1 mg administered subcutaneously (under the skin)

Primary outcomes

  1. Area under the liraglutide plasma concentration time curve (AUC 0-t)

Secondary outcomes

  1. Area under the liraglutide plasma concentration time curve (AUC 0-infinity)

  2. Cmax, maximum liraglutide plasma concentration

  3. tmax, time to reach Cmax

  4. t½, terminal plasma elimination half-life

  5. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Open Label, Single Dose Trial With Two Groups Comparing the Pharmacokinetics of Liraglutide in Young Versus Elderly Healthy Subjects of Both Sexes

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Jan 10, 2012
Registry last updated
Jan 24, 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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