Safety and Tolerability of Liraglutide in Healthy Japanese Volunteers

This study has been completed.

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01620476

First received: June 13, 2012

Last updated: NA

Last verified: June 2012

History: No changes posted

Tracking Information

First Received Date ^ICMJE

June 13, 2012

Last Updated Date

June 13, 2012

Start Date ^ICMJE

September 2003

Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Area under the plasma liraglutide curve [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Cmax, maximum plasma liraglutide concentration [ Designated as safety issue: No ]
tmax, time to reach Cmax [ Designated as safety issue: No ]
Terminal phase elimination rate-constant [ Designated as safety issue: No ]
t½, terminal elimination half life [ Designated as safety issue: No ]
24-hour profiles of serum insulin [ Designated as safety issue: No ]
24-hour profiles of serum glucose [ Designated as safety issue: No ]
24-hour profiles of plasma glucagon [ Designated as safety issue: No ]
Adverse events [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Safety and Tolerability of Liraglutide in Healthy Japanese Volunteers

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Diabetes
Healthy

Intervention ^ICMJE

Drug: liraglutide
5 mcg/kg for 21 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data
Drug: liraglutide
5 mcg/kg for 7 days followed by 10 mcg/kg for 14 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data
Drug: liraglutide
5 mcg/kg for 7 days followed by 10 mcg/kg for 7 days followed by 15 mcg/kg for 7 days. Injected subcutaneously once daily
Drug: placebo
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1

Study Arm (s)

Experimental: 5 mcg/kg
Interventions:
- Drug: liraglutide
- Drug: placebo
Experimental: 10 mcg/kg
Interventions:
- Drug: liraglutide
- Drug: placebo
Experimental: 15 mcg/kg
Interventions:
- Drug: liraglutide
- Drug: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2004

Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

20 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01620476

Other Study ID Numbers ^ICMJE

NN2211-1551

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	Milan Zdravkovic, MD, PhD	Novo Nordisk
Study Director:	Akane Shimizu	Novo Nordisk Pharma Ltd.

Information Provided By

Novo Nordisk

Verification Date

June 2012

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

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