A 2-Part, Phase 1, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of Dual-burst Release of Xanomeline With Immediate-Release Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity (Part 1) and an Open-label Study to Assess the Effect of Omeprazole on the Pharmacokinetics of Dual-burst Release of Xanomeline With Immediate-Release Trospium Chloride in Healthy Adult Participants (Part 2)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses of KarXT + KarX-EC capsules versus KarXT capsules in healthy adult and elderly participants of Japanese ethnicity and to assess the effect of multiple doses of omeprazole on the exposure of xanomeline and trospium administered as KarXT + KarX-EC capsules in healthy adult participants.
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
Part 1 of this study is double-blind while Part 2 is open-label.
入排标准
- 年龄范围
- 19 Years 至 90 Years(Adult, Older 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
Group A
干预措施: KarXT (Drug)
Group A
干预措施: Placebo (Drug)
Group B
干预措施: KarXT (Drug)
Group B
干预措施: Placebo (Drug)
Group C
干预措施: KarXT (Drug)
Group C
干预措施: KarX-EC (Drug)
Group C
干预措施: Placebo (Drug)
Group D
干预措施: KarXT (Drug)
Group D
干预措施: KarX-EC (Drug)
Group D
干预措施: Omeprazole (Drug)
结局指标
主要结局
Number of participants with Adverse Events (AEs)
时间窗: Up to 28 days post last dose
Part 1
Number of participants with Serioues AEs (SAEs)
时间窗: Up to 28 days post last dose
Part 1
Number of participants with vital sign abnormalities
时间窗: Up to 28 days post last dose
Part 1
Body weight
时间窗: Up to 28 days post last dose
Part 1
Number of participants with 12-lead electrocardiogram abnormalities
时间窗: Up to 28 days post last dose
Part 1
Number of participants with physical examination abnormalities
时间窗: Up to 28 days post last dose
Part 1
Number of participants with clinical laboratory assessment abnormalities
时间窗: Up to 28 days post last dose
Part 1
Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: On Day 30
Part 1
Maximum observed plasma concentration (Cmax)
时间窗: Up to Day 29
Part 2
Time of maximum observed plasma concentration (Tmax)
时间窗: Up to Day 29
Part 2
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
时间窗: Up to Day 29
Part 2
Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))
时间窗: Up to Day 29
Part 2
Apparent total body clearance (CLT/F)
时间窗: Up to Day 29
Part 2
Apparent volume of distribution (Vz/F)
时间窗: Up to Day 29
Part 2
Terminal elimination half-life (T-HALF)
时间窗: Up to Day 29
Part 2
次要结局
- Tmax(Up to Day 29)
- AUC(0-24)(Up to Day 29)
- Cmax(Up to Day 29)
- AUC(TAU)(Up to Day 29)
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))(Up to Day 29)
- CLT/F(Up to Day 29)
- Vz/F(Up to Day 29)
- T-HALF(Up to Day 29)
- Number of participants with AEs(Up to 28 days post last dose)
- Number of participants with SAEs(Up to 28 days post last dose)
- Number of participants with vital sign abnormalities(Up to 28 days post last dose)
- Body weight(Up to 28 days post last dose)
- Number of participants with 12-lead electrocardiogram abnormalities(Up to 28 days post last dose)
- Number of participants with physical examination abnormalities(Up to 28 days post last dose)
- Number of participants with clinical laboratory assessment abnormalities(Up to 28 days post last dose)
- C-SSRS(On Day 30)
