NCT06049329已完成1 期
Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0487-0111 in Japanese Participants With Obesity
适应症
干预措施
相关药物
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 (TEAE)
研究概览
简要总结
The purpose of the study is to evaluate if a new study drug, NNC0487-0111, is safe and how it works in the participant's body, when given as an oral tablet to Japanese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NNC0487-0111
Experimental
Once-daily oral administration - 1 of 3 different doses
干预措施: NNC0487-0111 (Drug)
Placebo
Placebo Comparator
Once-daily oral administration - 1 of 3 different doses
干预措施: Placebo (NNC0487-0111) (Drug)
结局指标
主要结局
Number of treatment emergent adverse events (TEAE)
时间窗: From pre-dose on Day 1 until completion of the end of study visit Day 31
Number of events
次要结局
- AUC,MD; the area under the NNC0487-0111 plasma concentration-time curve after last multile dose(From pre-dose on Day 10 until Day 11 (24 hours post-dose))
- Cmax,MD; the maximum plasma concentration of NNC0487-0111 after last multiple dose(From pre-dose on Day 10 until completion of the end of study visit Day 31)
- tmax,MD; the time of maximum plasma concentration of NNC0487-0111 after last multiple dose(From pre-dose on Day 10 until completion of the end of study visit Day 31)
研究者
研究点 (1)
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