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

Novo Nordisk A/S31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2 Healthy

Interventions

liraglutide-depotDRUG

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.

placeboDRUG

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

Sex: MALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Evansville, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 0 and up to 21 days after treatment

Secondary Outcomes

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

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

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

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

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

Data from ClinicalTrials.gov

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