A Phase I, Randomised, Double Blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Once-daily Oral Doses of NNC0560-0004 in Healthy Humans, With an Additional Open Label Single Dose Cohort of CYP2D6 Poor Metabolizers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Part B: Number of treatment-emergent adverse events (TEAE)
研究概览
简要总结
In this trial, medicine NNC0560-0004 given in capsule form will be compared to placebo in healthy volunteers.
Participants will either get NNC0560-0004 or placebo. Which treatment they get is decided by chance.
This is a first in human trial, which means that this is the first time that NNC0560-0004 is given to humans.
The study will last for about two weeks plus the screening period (approximately 42 days) which in all is about 8 weeks.
Women must be of non-childbearing potential thus you cannot take part if you are pregnant, can become pregnant, breast-feeding or plan to get pregnant during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NNC0560-0004
The study will be conducted in 3 parts.
Participants will be randomized to receive NNC0560-0004 in Part A: Single ascending dose (SAD) Part B: Multiple ascending dose (MAD)
No randomisation - only active treatment in Part C: Single dose
干预措施: NNC0560-0004 (Drug)
Placebo (NNC0560-0004)
Participant will be randomized to receive placebo in:
Part A: Single ascending dose (SAD) Part B: Multiple ascending dose (MAD)
干预措施: Placebo (NNC0560-0004) (Drug)
结局指标
主要结局
Part B: Number of treatment-emergent adverse events (TEAE)
时间窗: From pre-dose (day 1) to end of study, Part B (up to day 26)
Number of events
Part C: Number of treatment-emergent adverse events (TEAE)
时间窗: From pre-dose (day 1) to end of study, Part C (up to day 84)
Number of events
Part A: Number of treatment-emergent adverse events (TEAE)
时间窗: From pre-dose (day 1) to end of study, Part A (up to day 13)
Number of events
次要结局
- Part A: Cmax, SD: the maximum plasma concentration of NNC0560-0004 after a single dose(From pre-dose (day 1) to end of study, Part A (up to day 13))
- Part A: tmax, SD: the time to maximum concentration of NNC0560-0004 after a single dose(From pre-dose (day 1) to end of study, Part A (up to day 13))
- Part A:t½, SD: the terminal half-life of NNC0560-0004 after a single dose(From pre-dose (day 1) to end of study, Part A (up to day 13))
- Part B: AUC0-24h, MD: the area under the NNC0560-0004 plasma concentration-time curve in the dosing interval after last dosing(From pre-dose on day 14 until end of study, Part B (up to day 26) (24 hours post-dose))
- Part B: Cmax, MD: the maximum plasma concentration of NNC0560-0004 after last dosing(From pre-dose on day 14 to end of study, Part B (up to day 26))
- Part B:tmax, MD: the time to maximum concentration of NNC0560-0004 after last dosing(From pre-dose on day 14 to end of study, Part B (up to day 26))
- Part B:t½, MD: the terminal half-life of NNC0560-0004 after last dosing(From pre-dose on day 14 to end of study, Part B (up to day 26))
- Part A: AUC0-∞, SD: the area under the NNC0560-0004 plasma concentration-time curve from time 0 to infinity after a single dose(From pre-dose (day 1) to end of study, Part A (up to day 13))
- Part C: AUC0-∞, SD: the area under the NNC0560-0004 plasma concentration-time curve from time 0 to infinity after a single dose(From pre-dose (day 1) to end of study, Part C (up to day 84))
- Part C: Cmax, SD: the maximum plasma concentration of NNC0560-0004 after a single dose(From pre-dose (day 1) to end of study, Part C (up to day 84))
- Part C: tmax, SD: the time to maximum concentration of NNC0560-0004 after a single dose(From pre-dose (day 1) to end of study, Part C (up to day 84))
- Part C: t½, SD: the terminal half-life of NNC0560-0004 after a single dose(From pre-dose (day 1) to end of study, Part C (up to day 84))