Diabetes, Diabetes Mellitus, Type 2, Healthy
Conditions
Brief summary
This trial is conducted in Europe. The aim of the trial is to evaluate the optimal dosing conditions for semaglutide (a long acting GLP-1 analogue) in healthy male subjects.
Interventions
DRUGsemaglutide
Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 120 mins, no food or liquid is allowed.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Good general health as judged by the investigator, based on medical history, physical examination, electrocardiogram (ECG), vital signs and clinical laboratory * Body mass index (BMI) of 18.5-30.0 kg/m\^2 (both inclusive)
Exclusion criteria
* Males who are sexually active and not surgically sterilised, who or whose partner(s): a. are not using adequate contraceptive methods (e.g. condom with spermicidal foam/gel/film/cream or contraceptives with a Pearl Index below 1%, such as implants, injectables, combined oral contraceptives, or hormonal intrauterine devices or diaphragm + spermicide) or b. do not refrain from sexual intercourse during the trial and until 30 days following the last dose of trial medication. In addition, subjects must not donate sperm for the duration of the trial and for 30 days following the last dose of trial medication or c. sterilization of either partner * Suffer from a life threatening disease or has a history of any clinically significant disease or disorder * History of acute idiopathic or chronic pancreatitis * Calcitonin value equal to or above 50 ng/L * Any clinically significant abnormal laboratory test results (haematology, biochemistry and urinalysis), as judged by the investigator and any of the following laboratory safety results (based on screening results): Amylase, lipase and creatinine, above upper normal range. Aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and gamma-glutamyl-transpeptidase (gamma-GT) above 1.5 times upper normal range (UNR). Thrombocytes below 0.75 times lower normal range (LNR) or above 1.25 times UNR. Leucocytes outside 3.0 to 11.0x10\^9/L (normal range is 3.91 to 8.77x10\^9/L. Sodium outside the range 130.0 to 150.0 mmol/L (normal range is 136-145 mmol/L). Potassium outside the range 3.0 to 5.5 mmol/L (normal range is 3.5 to 5.1 mmol/L) * Any clinically significant abnormal ECG, as judged by the investigator * Subjects who are smokers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC 0-24h; Area under the semaglutide concentration curve from time 0-24 hours after the 10th dosing | 0-24hrs after the 10th dosing |
Secondary
| Measure | Time frame |
|---|---|
| t1/2; the terminal half-life of semaglutide | Post-dose at day 10 |
| Cmax; The maximum plasma semaglutide concentration | Post-dose at day 10 |
| tmax; Time to maximum plasma semaglutide concentration | Post-dose at day 10 |
Countries
Germany
Outcome results
None listed