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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01620463
First received: June 13, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  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: NNC 90-1170
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 [ Designated as safety issue: No ]
  • Vital signs (Blood pressure) [ Designated as safety issue: No ]
  • Vital signs (Pulse rate) [ Designated as safety issue: No ]
  • ECG (ElectroCardioGram) [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the plasma NNC 90-1170 curve [ Designated as safety issue: No ]
  • Maximum plasma NNC 90-1170 concentration, Cmax [ Designated as safety issue: No ]
  • Time to maximum plasma NNC 90-1170 concentration, tmax [ Designated as safety issue: No ]
  • Terminal elimination half-life, t1/2 [ Designated as safety issue: No ]
  • 24-hour glucose profile in serum [ Designated as safety issue: No ]
  • 24-hour insulin profile in serum [ Designated as safety issue: No ]
  • 24-hour glucagon profile in plasma [ Designated as safety issue: No ]

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: NNC 90-1170
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
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

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620463

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Milan Zdravkovic Novo Nordisk A/S
Study Director: Akane Shimizu Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01620463     History of Changes
Other Study ID Numbers: NN2211-1326
Study First Received: June 13, 2012
Last Updated: June 13, 2012
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014