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Completed

NCT Number: NCT01620476

Safety and Tolerability of Liraglutide in Healthy Japanese Volunteers

This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of liraglutide in healthy Japanese male subjects.

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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

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy
  • Japanese
  • Body mass index (BMI) between 18 and 27 kg/m^2 inclusive

Exclusion criteria

  • Any clinical laboratory values deviated from the reference range at the laboratory
  • Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
  • Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
  • History of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders.
  • History of significant allergy or hypersensitivity
  • Known or suspected allergy to trial product or related products.
  • History of drug or alcohol abuse
  • Smokes more than 15 cigarettes, or the equivalent, per day andis unwilling to refrain from smoking whenever required for the trial procedure

Treatment and study plan

liraglutide

Drug

5 mcg/kg for 21 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data

Placebo

Drug

Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1

Primary outcomes

  1. Area under the plasma liraglutide curve

Secondary outcomes

  1. Cmax, maximum plasma liraglutide concentration

  2. tmax, time to reach Cmax

  3. Terminal phase elimination rate-constant

  4. t½, terminal elimination half life

  5. 24-hour profiles of serum insulin

  6. 24-hour profiles of serum glucose

  7. 24-hour profiles of plasma glucagon

  8. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Randomised, Double-blind, Single-centre, Placebo-controlled, 21-day Multiple s.c. Doses, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide (NNC 90-1170) in Healthy Japanese Male Subjects

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jun 15, 2012
Registry last updated
Jan 25, 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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