Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0385-0434 in Healthy, Male Japanese Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events (TEAEs)
研究概览
简要总结
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
- NNC0385-0434 (a potential new medicine) in one of three different doses: 15 mg, 40 mg, or 100 mg.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Placebo (NNC0385-0434 100 mg)
Oral placebo will be administered once-daily over 10 consecutive days
干预措施: Placebo (Drug)
NNC0385-0434 100 mg
100 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days
干预措施: NNC0385-0434 (Drug)
NNC0385-0434 15 mg
15 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days
干预措施: NNC0385-0434 (Drug)
Placebo (NNC0385-0434 15 mg)
Oral placebo will be administered once-daily over 10 consecutive days
干预措施: Placebo (Drug)
NNC0385-0434 40 mg
40 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days
干预措施: NNC0385-0434 (Drug)
Placebo (NNC0385-0434 40 mg)
Oral placebo will be administered once-daily over 10 consecutive days
干预措施: Placebo (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (TEAEs)
时间窗: From pre-dose (day 1) until completion of the post-treatment period at follow-up (day 65)
Count of events
次要结局
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))
- 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))