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Completed

NCT Number: NCT01507272

Safety and Tolerability of Liraglutide in Healthy Male Volunteers

This trial is conducted in Europe. The aim of this trial is to assess the safety and tolerability (maximum tolerated dose) after five ascending single doses of NNC 90-1170 (liraglutide).

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Manchester, M15 6SH, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male subjects of any ethnic origin
  • Written informed consent obtained. (The subject must give signed informed consent before any trial-related activities. Trial-related activities are any procedures that would not have been performed during the normal management of the subject)
  • Good general health based on medical history, physical and laboratory examinations, incl. ECG (electrocardiogram)
  • Body mass index within the range 20-27 kg/m^2, inclusive

Exclusion criteria

  • Any clinically significant abnormal laboratory test results or clinically significant abnormal ECG
  • History of alcoholism or drug addiction; positive results in the plasma urine screens for illicit drug
  • Alcohol intake within 48 hours of visit
  • Hepatitis B surface antigen (HBsAg), Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies
  • History of significant drug allergy or drug hypersensitivity
  • Smoke 5 cigarettes or more, or the equivalent per day and is unable to refrain from smoking during the 3 days prior to the dosing day and during the confinement period
  • Subjects who drink more than 8 cups of tea/coffee per day

Treatment and study plan

liraglutide

Drug

Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order

Other names: NNC 90-1170

Placebo

Drug

Administered s.c. After a wash-out of at least 7 days, a single i.v. (into the vein) dose is administered

Primary outcomes

  1. AUC (area under the curve)

Secondary outcomes

  1. Cmax, maximum concentration

  2. tmax, time to maximum concentration

  3. t½, terminal half-life

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Double-blind, Placebo-controlled, Dose Escalation Trial of Single Doses of NNC90-1170 to Assess Tolerability, Pharmacokinetics, Pharmacodynamics and Absolute Bioavailability in Healthy Male Subjects

Important dates

Study start
1999
Primary completion
1999
Study completion
1999
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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