NCT07257120已完成4 期
A Phase IV, Open-label, Single-group Study Evaluating KarXT Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants
Karuna Therapeutics, Inc., a Bristol Myers Squibb company1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年1月9日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Maximum observed concentration (Cmax) of KarXT in Milk
研究概览
简要总结
The purpose of this study is to characterize the PK of xanomeline and trospium in breast milk and plasma in healthy lactating female participants, following multiple oral administration of KarXT in healthy lactating participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants should have a body mass index (BMI) of 18.0 kg/m2 to 35.0 kg/m2, inclusive, and body weight ≥ 50 kg (110 lb), at screening.
- •Participants should have well-established lactation (ie, at least 4 weeks postpartum) and can produce stable milk product (ie, approximately 3 oz per 3 hours at screening) using the methods required for the study.
- •Participants should be willing to exclusively pump breast milk throughout the treatment period and during the 24-hour post last dose period of milk collection during the CRU domincile period.
- •Participants should agree not to breastfeed or provide milk to infant until after 96 hours post last dose.
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 as assessed by the investigator.
- •Participants must not have history or presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (eg, obstructive disorders [including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis]), endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
- •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
Maximum observed concentration (Cmax) of KarXT in Milk
时间窗: Up to Day 7
Time of maximum observed concentration (Tmax) of KarXT in Milk
时间窗: Up to Day 7
Area under the concentration-time curve from time zero to 12 hours post morning dose [AUC(0-12)] of KarXT in Milk
时间窗: Up to Day 7
Area under the concentration-time curve from time zero to 24 hours post morning dose [AUC(0-24)] of KarXT in Milk
时间窗: Up to Day 7
Average concentration (Cavg) of KarXT in Milk
时间窗: Up to Day 7
Amount of KarXT recovered in milk within 12 hours of dosing [AR(12)]
时间窗: Up to Day 7
Total amount of KarXT recovered in milk (AR)
时间窗: Up to Day 7
Milk-plasma ratio of KarXT (M/P)
时间窗: Up to Day 7
Calculated as milk AUC(0-12)/plasma AUC(0-12)
次要结局
- Cmax of KarXT in plasma(Up to Day 7)
- Tmax of KarXT in plasma(Up to Day 7)
- AUC (0-12) of KarXT in plasma(Up to Day 7)
- AUC (0-24) of KarXT in plasma(Up to Day 7)
- Cavg of KarXT in plasma(Up to Day 7)
- Estimated daily infant dosage of KarXT(Up to Day 7)
- Relative infant dosage of KarXT(Up to Day 7)
- Number of participants with Adverse Events (AEs)(Up to Day 34)
- Number of participants with Serious Adverse Events (SAEs)(Up to Day 34)
- Number of participants with physical examination abnormalities(Up to Day 7)
- Number of participants with vital signs abnormalities(Up to Day 7)
- Number of participants with 12-Lead electrocardiogram (ECG) abnormalities(Up to Day 7)
- Number of participants with clinical laboratory abnormalities(Up to Day 7)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to Day 7)
- Number of participants with Adverse Events of Special Interest (AESIs)(Up to Day 34)
研究者
研究点 (1)
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