Clinical trial NCT01513525: Comparison of Liraglutide Injected at Three Different Injection Sites in Healthy Volunteers
Official title: A Randomised, Open-label, Single Centre, Three Period Cross-over Trial in Healthy Subjects Comparing the Pharmacokinetic Profiles After Single Dose Administration of Liraglutide at Three Different Injection Sites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-20
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. the aim of this trial is to compare the pharmacokinetic profile of liraglutide between administrations in the thigh versus the abdomen and between administrations in the upper arm versus the abdomen.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Good general health as judged by the Investigator based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments
* BMI (Body Mass Index): 18.5-27.5 kg/m\^2, both inclusive

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods as required by local law or practice
* The receipt of any investigational drug within 3 months prior to this trial
* History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator
* Impaired renal function
* Active hepatitis B and/or active hepatitis C
* Positive human immunodeficiency virus (HIV) antibodies
* Use of any prescription or non-prescription medication, except for paracetamol and vitamins
* History of alcoholism or drug abuse during the last 12 months.
* Smoking
* Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the Investigator
* Excessive consumption of a diet deviating from a normal diet as judged by the Investigator
* Blood donation within the last 3 months
* Plasma donation within the last month

Primary outcomes:
measure: Area under the Curve (AUC) of liraglutide for each injection site
Secondary outcomes:
measure: AUC
measure: Cmax, maximum concentration
measure: tmax, time to maximum concentration
measure: t½, terminal half-life
measure: Terminal elimination rate constant
measure: Relative Bioavailability
measure: Adverse events
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kapitza C, Zdravkovic M, Zijlstra E, Segel S, Heise T, Flint A. Effect of three different injection sites on the pharmacokinetics of the once-daily human GLP-1 analogue liraglutide. J Clin Pharmacol. 2011 Jun;51(6):951-5. doi: 10.1177/0091270010374474. Epub 2010 Jul 29. No abstract available.