A Research Study Looking at How a Single Dose of the Medicine NNC0194-0499 Behaves in Chinese Men
- Conditions
- Non-alcoholic Fatty Liver Disease
- Interventions
- Drug: NC0194-0499
- Registration Number
- NCT05742919
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study looks at how a new study medicine called NNC0194-0499 behaves in the body of Chinese men. Three different dose levels will be tested. Participant will get only one of the three different dose levels of NNC0194-0499. Which dose participant will get will be decided by chance. NNC0194-0499 is a medicine under clinical investigation. It means that the medicine has not yet been approved by the health authorities. Participant will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on stomach. The study will last for a maximum of 64 days. Participant will not be able to take part in the study if the study doctor considers there is a risk for participant's health.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- Chinese male aged 20-55 years (both inclusive) at the time of signing informed consent.
- Body mass index (BMI) between 23.0 and 34.9 kilograms per meter square (kg/m^2) (both inclusive).
- Body weight greater than or equal to 60 kg.
- Considered eligible 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.
- Known or suspected hypersensitivity to study intervention or related products.
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NNC0194-0499 12 mg NNC0194-0499 Participants will receive a single subcutaneous (s.c.) dose of 12 milligrams (mg) NNC0194-0499 on Day 1. NNC0194-0499 96 mg NC0194-0499 Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1. NNC0194-0499 30 mg NNC0194-0499 Participants will receive a single s.c. dose of 30 mg NNC0194-0499 on Day 1.
- Primary Outcome Measures
Name Time Method AUC0-∞, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) Measured in nanomoles\*hours per liter (nmol h/L).
- Secondary Outcome Measures
Name Time Method AUC0-168h, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single dose From Day 1 (pre-dose) until Day 7 (168 hours) Measured in nmol h/L.
t1/2, NNC0194-0499: The terminal half-life of NNC0194-0499 From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) Measured in hours.
Vz/FNNC0194-0499: The apparent volume of distribution of NNC0194-0499 in the terminal phase From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) Measured in liters (L).
Cmax, NNC0194-0499: The maximum concentration of NNC0194- 0499 in serum From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) Measured in nmol/L.
tmax, NNC0194-0499: The time from dose administration to maximum serum concentration of NNC0194-0499 From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) Measured in hours.
CL/FNNC0194-0499: The apparent total serum clearance of NNC0194-0499 From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) Measured in liters per hour (L/h).
Relative change in triglycerides From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) Measured in Percent change.
Relative change in high-density lipoprotein (HDL) cholesterol From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) Measured in Percent change.
Relative change in low-density lipoprotein (LDL) cholesterol From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) Measured in Percent change.
Trial Locations
- Locations (1)
Jinan Central Hospital
🇨🇳Jinan, Shandong, China