Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects
Investigation on Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects. A Randomised, Double-blind, Placebo-controlled Trial Investigating Subcutaneously Single Dose Escalation of a Sustained Release Formulation of Liraglutide Lysine in Healthy Male Subjects
2 other identifiers
interventional
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 diabetes
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 2, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
September 4, 2013
CompletedMarch 23, 2017
March 1, 2017
5 months
November 2, 2011
June 20, 2013
March 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Treatment Emergent Adverse Events (TEAEs)
TEAEs: AEs from 1st exposure (exp) until follow-up (FU) or AEs with onset before 1st exp increasing in severity up to the FU. Mild AEs: no or transient symptoms, no interference (inf) with subject's daily activities. Moderate AEs: marked symptoms, moderate inf with subject's daily activities. Severe AEs: considerable inf with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in death/ a life-threatening experience/ in-subject hospitalization/prolongation of existing hospitalisation; or persistent/significant disability/incapacity/congenital anomaly/birth defect.
Day 0 and up to 21 days after treatment
Secondary Outcomes (6)
Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot
Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot
Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity
Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment
1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose
Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment
0 to 168 hours after dosing
- +1 more secondary outcomes
Study Arms (5)
Cohort 1a: Lira-depot 2.25 mg
EXPERIMENTALCohort 2a: Lira-depot 6.75 mg
EXPERIMENTALCohort 3a: Lira-depot 15 mg
EXPERIMENTALCohort 4a: Lira-depot 30 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
Subjects will be randomised to receive a single dose of liraglutide-depot placebo, at increasing dose levels, injected s.c./subcutaneously (under the skin).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Evansville, Indiana, 47710, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Public Access to Clinical Trials
- Organization
- Novo Nordisk A/S
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2011
First Posted
November 17, 2011
Study Start
October 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
March 23, 2017
Results First Posted
September 4, 2013
Record last verified: 2017-03