Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology, Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 3/24/2017 |
| Start Date: | October 2011 |
| End Date: | March 2012 |
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.
investigate the safety, tolerability and pharmacokinetics (exposure in the body) of
liraglutide-depot in healthy subjects.
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
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