Healthy Volunteers Type 2 Diabetes
Conditions
Brief summary
This study is conducted to compare four different tablets containing the investigational medicine semaglutide at the same dose. It is done to test how semaglutide in each of the tablet versions is taken up in the body. Which treatments participants will receive is decided by chance. The study will last for about 28 weeks. The study will enroll healthy male participants.
Interventions
DRUGSemaglutide B
Semaglutide B will be administered subcutaneously.
DRUGSemaglutide J
Semaglutide J will be administered as oral tablets.
DRUGSemaglutide L
Semaglutide L will be administered as oral tablets.
DRUGSemaglutide M
Semaglutide M will be administered as oral tablets.
DRUGSemaglutide N
Semaglutide N will be administered as oral tablets.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male. 2. Age 18-64 years (both inclusive) at the time of signing the informed consent. 3. Body mass index (BMI) between 22.0 and 31.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. 4. Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion criteria
1. Known or suspected hypersensitivity to study interventions or related products. 2. Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. 3. Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen, within 14 days prior to first dosing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted AUC(sema); adjusted area under the semaglutide plasma concentration-time curve | From 0 to 24 hours after dosing on Days 122 and 132. | Measured in hours nanomoles per liter (h \* nmol/L). |
| Adjusted Cmax,(sema); adjusted maximum observed semaglutide plasma concentration | From 0 to 24 hours after dosing on Days 122 and 132. | Measured in nanomoles per liter(nmol/L). |
| Adjusted tmax,sema; time to adjusted maximum observed semaglutide plasma concentration | From 0 to 24 hours after dosing on Days 122 and 132. | Measured in hours. |
| t½,sema; the terminal half-life of semaglutide | From 0 to 840 hours after dosing on Day 132. | Measured in hours. |
Countries
Canada
Outcome results
None listed