Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects

This study has been completed.

Sponsor:

Information provided by:

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01473953

First received: November 2, 2011

Last updated: April 4, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 2, 2011

Last Updated Date

April 4, 2012

Start Date ^ICMJE

October 2011

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Number of treatment emergent adverse events (TEAE) reported based on clinical observations [ Time Frame: from first trial related activity (day 1) until completion of last post-treatment follow-up visit (day 21) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01473953 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Maximum concentration of liraglutide [ Time Frame: Day 0 through day 21 ] [ Designated as safety issue: No ]
Time to maximum concentration of liraglutide [ Time Frame: Day 0 through day 21 ] [ Designated as safety issue: No ]
Area under the plasma concentration curve in the period from the time of liraglutide-depot administration to infinity [ Time Frame: Day 0 through day 21 ] [ Designated as safety issue: No ]
Area under the plasma concentration curve in the first week following liraglutide-depot administration for subjects without liraglutide 6 mg/ml pre-treatment [ Time Frame: Day 0 through day 21 ] [ Designated as safety issue: No ]
Area under the plasma concentration curve in the first week following liraglutide-depot administration for subjects with liraglutide 6 mg/ml pre-treatment [ Time Frame: Day 0 through day 21 ] [ Designated as safety issue: No ]
Antibodies against liraglutide observed at pre-dose and at last follow-up [ Time Frame: Day 0 and day 21 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects

Official Title ^ICMJE

Investigation on Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects

Brief Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics (exposure in the body) of liraglutide-depot in healthy subjects.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 2
Healthy

Intervention ^ICMJE

Drug: liraglutide-depot
Subjects will be randomised to receive a single dose of liraglutide-depot, at increasing dose levels, injected s.c./subcutaneously (under the skin). Progression to next dose level (max. 8) will be based on safety evaluation.
Drug: liraglutide
Subjects will receive treatment for 3-4 weeks with liraglutide (6 mg/ml), injected s.c./subcutaneously (under the skin), before receiving treatment with liraglutide-depot.
Drug: placebo
Subjects will be randomised to receive a single dose of liraglutide-depot placebo, at increasing dose levels, injected s.c./subcutaneously (under the skin).

Study Arm (s)

Experimental: Without liraglutide pre-treatment
Interventions:
- Drug: liraglutide-depot
- Drug: placebo
Experimental: With liraglutide pre-treatment
Interventions:
- Drug: liraglutide-depot
- Drug: liraglutide
- Drug: placebo

Publications *

Not Provided

* 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 2012

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Body mass index (BMI) between 20 and 35 kg/m^2 (both inclusive) with a body weight of at least 60 kg
Apart from being obese (BMI above 30 kg/m^2) the subject has to be considered generally healthy

Exclusion Criteria:

Medical history of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine, haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders
Clinical or laboratory findings which suggest that the subject cannot be considered generally healthy
Prescription medicine and non-prescription medicine with few exceptions
Current and prior history of alcohol or drug abuse
Current smoking of more than 5 cigarettes per day
Mental incapacity, language barriers, or unwillingness to comply with the protocol

Gender

Male

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01473953

Other Study ID Numbers ^ICMJE

NN9223-3928, U1111-1123-0547

Has Data Monitoring Committee

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Stine Just Maarbjerg

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

April 2012

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

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