Clinical trial NCT01473953: Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-11-17
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Treatment Emergent Adverse Events (TEAEs)
timeFrame: Day 0 and up to 21 days after treatment
Secondary outcomes:
measure: Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot
timeFrame: Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
measure: Time to Maximum Plasma Concentration of Liraglutide After a Single Dose of Liraglutide-depot
timeFrame: Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
measure: Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity
timeFrame: Day 0 through day 21 at 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168, 336, 504 hours post dose
measure: Area Under the Liraglutide Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects Without Liraglutide 6 mg/ml Pre-treatment
timeFrame: 1,3,6,12,18, 24, 36, 48, 72, 96, 120, 168 hours post dose
measure: Area Under the Plasma Concentration Curve in the First Week Following Liraglutide-depot Administration for Subjects With Liraglutide 6 mg/ml Pre-treatment
timeFrame: 0 to 168 hours after dosing
measure: Number of Subjects With Antibodies (Positive) or Without Antibodies (Negative) Against Liraglutide Observed at Pre-dose and at Last Follow-up
timeFrame: Day 0 and Day 21
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: