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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Healthy Japanese Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01620463
First Posted: June 15, 2012
Last Update Posted: January 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of NNC 90-1170 (liraglutide) in healthy Japanese male subjects.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide Drug: placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Single-centre, Placebo-controlled, Ascending Single s.c. Dose, Sequential Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC 90-1170 in Healthy Japanese Male Subjects

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Body weight
  • Vital signs (Blood pressure)
  • Vital signs (Pulse rate)
  • ECG (ElectroCardioGram)
  • Adverse events

Secondary Outcome Measures:
  • Area under the plasma NNC 90-1170 curve
  • Maximum plasma NNC 90-1170 concentration, Cmax
  • Time to maximum plasma NNC 90-1170 concentration, tmax
  • Terminal elimination half-life, t1/2
  • 24-hour glucose profile in serum
  • 24-hour insulin profile in serum
  • 24-hour glucagon profile in plasma

Enrollment: 32
Study Start Date: December 2002
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NNC 90-1170 Drug: liraglutide
Single dose administered subcutaneously at four different dose levels: 2.5, 5.0, 10.0 and 15.0 mcg/kg. Following completion of each dose group, an evaluation will be performed to allow progression to the next dose group
Other Name: NNC 90-1170
Placebo Comparator: Placebo Drug: placebo
Single dose administered subcutaneously at four different dose levels: 2.5, 5.0, 10.0 and 15.0 mcg/kg. Following completion of each dose group, an evaluation will be performed to allow progression to the next dose group

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI) between 18 and 27 kg/m^2, inclusive

Exclusion Criteria:

  • Clinically relevant abnormalities of physical examination, laboratory values, vital signs or ECG findings at the screening, as judged by the Investigator or Sub-Investigator
  • Presence of acute or chronic illness sufficient to invalidate the subject's participation in the study or to make it unnecessarily hazardous, as judged by the Investigator
  • Blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90-150 mmHg systolic or 40-90 mmHg diastolic
  • Heart rate in supine position at the screening, after resting for 5 min, outside the range 40-100 beats/min
  • Alcohol intake within 48 hours prior to the screening
  • Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
  • Clinically relevant abnormal history or physical findings at the screening, which could interfere with the objectives of the study or the safety of the subject's participation, as judged by the Investigator
  • History of significant allergy or hypersensitivity
  • Known or suspected allergy to trial product or related products
  • History of drug or alcohol abuse
  • Smoking 10 cigarettes or more, or the equivalent, per day and is unwilling to refrain from smoking during 3 days prior to dosing and during the confinement period
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620463


Locations
Japan
Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Kageyama S, Hirao K, Shimizu A, Matsumura Y, Zdravkovic M, Rasmussen MF, Irie S. Tolerability, pharmacokinetics, and pharmacodynamics of liraglutide, long-acting human GLP-1 analogue - Phase 1 studies in Japanese healthy subjects with type 2 diabetes. Endocrinology and Diabetology 2007; 24 (6): 95-104

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01620463     History of Changes
Other Study ID Numbers: NN2211-1326
First Submitted: June 13, 2012
First Posted: June 15, 2012
Last Update Posted: January 24, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists