Non-alcoholic Steatohepatitis
Conditions
Brief summary
This study looks at how a new medicine called NNC0194-0499 works in the body of Japanese men and non-Asian men. Japanese participants will either get NNC0194-0499 or placebo - which treatment participants get is decided by chance. Non-Asian participants will get NNC0194-0499. Participants will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on the stomach. The study will last for a maximum of 66 days. Participants will have 8 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights). The study includes blood sampling. Participants will not be able to take part in the study if the study doctor thinks there is a risk for participants health.
Interventions
DRUGNNC0194-0499
1 single dose administered subcutaneously (s.c. - under the skin)
DRUGPlacebo (NNC0194-0499 )
1 single dose administered subcutaneously (s.c. - under the skin).
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The non-Asian part is run in parallel to the Japanese part in an open design. The Japanese part is double-blinded. Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Intervention model description
The present trial is split into two parts reflecting the two trial populations: Japanese subjects and non-Asian subjects. For the Japanese part, it is designed as a randomised, placebo-controlled, double-blinded within cohorts, parallel group, single-dose trial. The non-Asian part is run in parallel to the Japanese part in an open design
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male, aged 20-55 years (both inclusive) at the time of signing informed consent * For Japanese subjects only, both parents of Japanese descent. For non-Asian subjects only, both parents of non-Asian descent * Body mass index (BMI) between 23.0 and 34.9 kg/m\^2 (both inclusive) * Body weight greater than or equal to 60 kg
Exclusion criteria
* Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol * Subjects aged above or equal to 40 years with an estimated 10-year atherosclerotic cardiovascular disease risk (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) greater than or equal to 5 percentage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | From Day 1 (pre-dose) until completion of the post-treatment period at follow-up (Day 36) | Count of events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-tz, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to the time of the last quantifiable sample after a single s.c. administration | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | h·nmol/L |
| AUC0-168h, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single s.c. administration | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | h·nmol/L |
| Cmax, SD: Maximum concentration of NNC0194-0499 in serum after a single s.c. administration | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | nmol/L |
| tmax, SD: Time from dose administration to maximum serum concentration of NNC0194-0499 after a single s.c. administration | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | Hours |
| AUC0-∞, SD: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single s.c.(subcutaneous) administration | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | h·nmol/L |
| CL/FSD: Apparent total serum clearance of NNC0194-0499 | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | L/h |
| Vz/FSD: 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) | L |
| MRTSD: The mean residence time of NNC0194-0499 after a single s.c. administration | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | Hours |
| t½, SD: Terminal half-life of NNC0194-0499 | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | Hours |
Countries
Japan
Outcome results
None listed