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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01473953
First received: November 2, 2011
Last updated: October 11, 2013
Last verified: October 2013

November 2, 2011
October 11, 2013
October 2011
March 2012   (final data collection date for primary outcome measure)
Number of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Day 0 and up to 21 days after treatment ] [ Designated as safety issue: No ]
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.
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 ]
Complete list of historical versions of study NCT01473953 on ClinicalTrials.gov Archive Site
  • Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot [ Time Frame: Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose ] [ Designated as safety issue: No ]
  • Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot [ Time Frame: Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose ] [ 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 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose ] [ Designated as safety issue: No ]
  • Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment [ Time Frame: 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose ] [ 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: 0 to 168 hours after dosing ] [ Designated as safety issue: No ]
  • Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up [ Time Frame: Day 0 and Day 21 ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
Not Provided
 
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

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.

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
  • Healthy
  • 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: 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).
  • Experimental: Cohort 1a: Lira-depot 2.25 mg
    Intervention: Drug: liraglutide-depot
  • Experimental: Cohort 2a: Lira-depot 6.75 mg
    Intervention: Drug: liraglutide-depot
  • Experimental: Cohort 3a: Lira-depot 15 mg
    Intervention: Drug: liraglutide-depot
  • Experimental: Cohort 4a: Lira-depot 30 mg
    Intervention: Drug: liraglutide-depot
  • 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
31
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01473953
NN9223-3928, U1111-1123-0547
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Stine Just Maarbjerg Novo Nordisk A/S
Novo Nordisk A/S
October 2013

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