A Research Study Looking at How the Medicine NNC0385-0434 Works in the Body of Healthy Japanese Men
- Conditions
- Atherosclerotic Cardiovascular DiseaseHealthy Volunteers
- Interventions
- Drug: Placebo
- Registration Number
- NCT05003440
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
The aim of this study is to look at how the study medicine works in the body and how it is removed from the body.
We are testing the study medicine to make a medicine that can help people lower their cholesterol level.
Participants will either get
1. NNC0385-0434 (a potential new medicine) in one of three different doses: 15 mg, 40 mg, or 100 mg.
2. placebo (a dummy medicine which looks like the study medicine but without any medicine).
Which treatment participants get is decided by chance. NNC0385-0434 is a new medicine and has not been approved by the Health Authorities (Centre for Drug Evaluation).
Participants will get 1 tablet per day for 10 days. The tablet will be handed out by a study doctor or site staff at the clinic and the study will last between 62 and 98 days.
Participants will have 7 clinic visits. One of these visits will be a 13-day, 12-night stay (V2) and the rest will be 1-day visits (V1 and V3 to V7).
At all visits, except the information visit, participants will have blood drawn along with other clinical checks.
Participants will be asked about their health, medical history and habits including mental health.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 36
- Body weight greater than or equal to 54.0 kg.
- Body mass index (BMI) between 20.0 and 34.9 kg/m^2 (both inclusive).
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
- 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
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo (NNC0385-0434 40 mg) Placebo Oral placebo will be administered once-daily over 10 consecutive days Placebo (NNC0385-0434 100 mg) Placebo Oral placebo will be administered once-daily over 10 consecutive days NNC0385-0434 40 mg NNC0385-0434 40 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days Placebo (NNC0385-0434 15 mg) Placebo Oral placebo will be administered once-daily over 10 consecutive days NNC0385-0434 15 mg NNC0385-0434 15 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days NNC0385-0434 100 mg NNC0385-0434 100 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days
- Primary Outcome Measures
Name Time Method Number of treatment emergent adverse events (TEAEs) From pre-dose (day 1) until completion of the post-treatment period at follow-up (day 65) Count of events
- Secondary Outcome Measures
Name Time Method t½,SNAC,Day10; the terminal half-life of SNAC after last dose of oral NNC0385-0434 From last dose (day 10) 0 to 24 hours post treatment follow-up (day 11) hours
AUC0-24h,SNAC,Day10,; the area under the SNAC plasma concentration-time curve from time 0 to 24 h after last dose of oral NNC0385-0434 From last dose (day 10) 0 to 24 hours post treatment (day 11) h\*nmol/L
tmax,SNAC,Day10; the time to maximum observed plasma concentration of SNAC after last dose of oral NNC0385-0434 From last dose (day 10) 0 to 24 hours post treatment follow-up (day 11) hours
AUC0-24h,0434,Day10,; the area under the NNC0385-0434 plasma concentration-time curve from time 0 to 24 h after last dose of oral NNC0385-0434 From last dose (day 10) 0 to 24 hours post treatment (day 11) h\*nmol/L
Cmax,0434,Day10,; the maximum plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434 From last dose (day 10) 0 hours to post treatment follow-up (day 65) nmol/L
t½,0434,Day10; the terminal half-life of NNC0385-0434 after last dose of oral NNC0385-0434 From last dose (day 10) 0 hours to post treatment follow-up (day 65) hours
Cmax,SNAC,Day10; the maximum plasma concentration of SNAC after last dose of oral NNC0385-0434 From last dose (day 10) 0 to 24 hours post treatment (day 11) nmol/L
tmax,0434,Day10; the time to maximum observed plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434 From last dose (day 10) 0 hours to post treatment follow-up (day 65) hours
Trial Locations
- Locations (1)
Hakata Clinic
🇯🇵Fukuoka, Japan