A Research Study Looking at How the Medicine NNC0194-0499 Behaves in Japanese and Non-Asian Men
Phase 1
Completed
- Conditions
- Non-alcoholic Steatohepatitis
- Interventions
- Drug: Placebo (NNC0194-0499 )
- Registration Number
- NCT04722653
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 42
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo (NNC0194-0499 ) Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo. NN0194-0499 NNC0194-0499 Japanese participants will be randomised 3:1 to receive either a single dose of NNC0194-0499 or placebo, Asian participants will only receive NNC0194-0499. There will be 3 cohorts with escalating dose levels. There should be at least 4 days between dose administration of the last participant in a dose level cohort and dose administration of the first participant in the following dose level cohort.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
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
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
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
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
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
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇯🇵Tokyo, Japan