- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01620463
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Healthy Japanese Volunteers
January 23, 2017 updated by: Novo Nordisk A/S
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tokyo, Japan, 1000005
- Novo Nordisk Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 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
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Adverse events
|
Body weight
|
Vital signs (Blood pressure)
|
Vital signs (Pulse rate)
|
ECG (ElectroCardioGram)
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2002
Primary Completion (Actual)
March 1, 2003
Study Completion (Actual)
March 1, 2003
Study Registration Dates
First Submitted
June 13, 2012
First Submitted That Met QC Criteria
June 13, 2012
First Posted (Estimate)
June 15, 2012
Study Record Updates
Last Update Posted (Estimate)
January 24, 2017
Last Update Submitted That Met QC Criteria
January 23, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN2211-1326
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
HighTide Biopharma Pty LtdRecruitingT2DM (Type 2 Diabetes Mellitus)China
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
Clinical Trials on liraglutide
-
Woman'sNovo Nordisk A/SCompletedPolycystic Ovary Syndrome | Pre Diabetes | Obesity AndroidUnited States
-
Novo Nordisk A/SCompleted
-
The Affiliated Hospital of Qingdao UniversityCompletedTherapeutic EquivalencyChina
-
Sunshine Lake Pharma Co., Ltd.Completed
-
Merck Sharp & Dohme LLCCompleted
-
Henrik GudbergsenCompletedObesity | OsteoarthritisDenmark
-
Parker Research InstituteCompletedOsteoarthritis, KneeDenmark
-
Henrik GudbergsenNovo Nordisk A/S; Cambridge Weight Plan LimitedCompleted
-
Henrik GudbergsenCompletedUltrasound of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance (US-LOSEIT-II)Obesity | OsteoarthritisDenmark
-
Henrik GudbergsenCompletedObesity | OsteoarthritisDenmark