NCT07204418招募中1 期
A Phase 1, 4-part, Open-label Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants
Karuna Therapeutics3 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年10月13日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 3
- 主要终点
- Geometric mean ratio for the area under the concentration-time curve from time zero to 12 hours post morning dose (AUC(0-12))
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (PK) of xanomeline following administration of KarXT in CYP2D6 normal/extensive, intermediate, poor, and ultrarapid metabolizers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be healthy male and female (INOCBP) participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs (VS), and clinical laboratory determinations.
- •Participant must be a normal/extensive, intermediate, poor, or ultrarapid CYP2D6 metabolizer.
- •Participant must have body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
排除标准
- •Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population reference ranges.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
KarXT
Experimental
干预措施: Xanomeline/ Trospium Chloride (Drug)
结局指标
主要结局
Geometric mean ratio for the area under the concentration-time curve from time zero to 12 hours post morning dose (AUC(0-12))
时间窗: Up to Day 17
次要结局
- Number of participants with Adverse Events (AEs)(Up to 28 days post last dose)
- Number of participants with Serious Adverse Events (SAEs)(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 vital sign abnormalities(Up to 28 days post last dose)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 28 days post last dose)
- Number of participants with clinical laboratory test abnormalities(Up to 28 days post last dose)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to 28 days post last dose)
- Number of participants with AEs of Special Interest (AESIs)(Up to 28 days post last dose)
研究者
研究点 (3)
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