跳至主要内容
临床试验/NCT06605950
NCT06605950已完成1 期

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)

Karuna Therapeutics1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2024年10月1日最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Group A

Experimental

干预措施: KarXT (Drug)

Group A

Experimental

干预措施: Placebo (Drug)

Group B

Experimental

干预措施: KarXT (Drug)

Group B

Experimental

干预措施: Placebo (Drug)

Group C

Experimental

干预措施: KarXT (Drug)

Group C

Experimental

干预措施: KarX-EC (Drug)

Group C

Experimental

干预措施: Placebo (Drug)

Group D

Experimental

干预措施: KarXT (Drug)

Group D

Experimental

干预措施: KarX-EC (Drug)

Group D

Experimental

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)

研究者

发起方
Karuna Therapeutics
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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