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

Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 2; Healthy

Intervention: liraglutide-depot (Drug); liraglutide (Drug); placebo (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Stine Just Maarbjerg, Study Director, Affiliation: Novo Nordisk

Overall contact:
Novo Nordisk Clinical Trial Call Center, Phone: 866-867-7178

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.

Official title: Investigation on Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Number of treatment emergent adverse events (TEAE) reported based on clinical observations

Secondary outcome:

Maximum concentration of liraglutide

Time to maximum concentration of liraglutide

Area under the plasma concentration curve in the period from the time of liraglutide-depot administration to infinity

Area under the plasma concentration curve in the first week following liraglutide-depot administration for subjects without liraglutide 6 mg/ml pre-treatment

Area under the plasma concentration curve in the first week following liraglutide-depot administration for subjects with liraglutide 6 mg/ml pre-treatment

Antibodies against liraglutide observed at pre-dose and at last follow-up

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

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

Novo Nordisk Clinical Trial Call Center, Phone: 866-867-7178

Novo Nordisk Clinical Trial Call Center, Evansville, Indiana 47710, United States; Recruiting

Clinical Trials at Novo Nordisk

Starting date: October 2011
Last updated: November 14, 2011