Healthy Volunteers; High Cholesterol
Conditions
Brief summary
In this study, the study drug 'NNC0385-0434' will be tested in 3 different tablet formulations. These formulations are being tested for the treatment of hypercholesterolemia (high cholesterol). Participants will only receive 2 of the 3 tablet formulations. The treatments participants get are decided by chance. Participants will receive 1 formulation for 10 days (first treatment period) and the other formulation for 5 days (second treatment period). The study will last up to 96 days. Only men can participate in this clinical study.
Interventions
DRUGNNC0385-0434 G
Participants will receive oral dose of NNC0385-0434 G tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
DRUGNNC0385-0434 F
Participants will receive oral dose of NNC0385-0434 F tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
DRUGNNC0385-0434 B
Participants will receive oral dose of NNC0385-0434 B tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
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 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Male * Aged 18-64 years (both inclusive) at the time of signing informed consent * Body mass index between 20.0 and 32.0 kilogram per meter square (both inclusive) * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
Exclusion criteria
* Known or suspected hypersensitivity to study interventions or related products * Use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening * Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol * Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator * History of major surgical procedures involving the stomach potentially affecting absorption of study products (example: subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval | From 0 to 24 hours after dose administration on visit 2, day 10 | Measured in h \* nmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax,NNC0385-0434,day10; maximum observed plasma concentration of NNC0385-0434 | From 0 to 24 hours after dose administration on visit 2, day 10 | Measured in nmol/L |
| tmax,NNC0385-0434,day10; time from dose administration to maximum observed plasma concentration of NNC0385- 0434 | From 0 to 24 hours after dose administration on visit 2, day 10 | Measured in hours |
Countries
United States
Outcome results
None listed