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

June 13, 2012
June 13, 2012
December 2002
March 2003   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Healthy Japanese Volunteers
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • 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
  • 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
  • Experimental: NNC 90-1170
    Intervention: Drug: NNC 90-1170
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
March 2003
March 2003   (final data collection date for primary outcome measure)

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
Male
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01620463
NN2211-1326
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Milan Zdravkovic Novo Nordisk A/S
Study Director: Akane Shimizu Novo Nordisk Pharma Ltd.
Novo Nordisk A/S
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP