NCT07681076尚未招募4 期
A Phase 4, Randomized, Open Label Study to Evaluate the Safety and Tolerability of Twice Daily Xanomeline/Trospium Chloride (KarXT) With Prophylactic and PRN Antiemetic Use in Healthy Volunteers
Karuna Therapeutics, Inc., a Bristol Myers Squibb company0 个研究点目标入组 225 人开始时间: 2026年8月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 225
- 主要终点
- Number of participants with Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study looks at how to reduce nausea and vomiting in people taking KarXT which is used to treat mental health conditions like schizophrenia. KarXT can cause stomach-related side effects, especially in the first couple of weeks. In this study, healthy volunteers will take KarXT along with anti-nausea medication, either regularly (to prevent symptoms) or as needed.
The goal is to see how well these strategies help reduce nausea and vomiting and how safe the combination is. The results will help doctors better manage side effects and make treatment more comfortable for patients starting KarXT.
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
- 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
- •Participants must be healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, VS, and clinical laboratory determinations.
- •Participants must be willing and able to be confined to an inpatient setting for a 3-week duration, follow instructions, and comply with the protocol requirements.
- •Participants must have BMI ≥ 18 and ≤ 40 kg/m
- •Individuals of childbearing potential (IOCBP) must be willing and able to adhere to the contraception guidelines.
排除标准
- •Participants must not have history or presence of clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, gastrointestinal ([GI] eg, obstructive disorders [including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis], active biliary disease [including symptomatic gallstones]), 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.
- •Participants must not have history of moderate to severe alcohol use disorder or a substance (other than nicotine or caffeine) use disorder within the past 12 months or a positive urine drug screen (UDS) for a substance other than cannabis at screening or baseline.
- •Participants must not have history or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
- •Participants must not have active biliary disease (eg, symptomatic gallstones). Participants with other biliary histories are eligible and should be discussed with the medical monitor.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Arm 1
Experimental
干预措施: KarXT (Drug)
Arm 2
Experimental
干预措施: KarXT (Drug)
Arm 1
Experimental
干预措施: Trimethobenzamide (Drug)
Arm 4
Experimental
干预措施: KarXT (Drug)
Arm 3
Experimental
干预措施: Meclizine (Drug)
Arm 2
Experimental
干预措施: Ondansetron (Drug)
Arm 3
Experimental
干预措施: KarXT (Drug)
结局指标
主要结局
Number of participants with Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to Day 21
Nausea and vomiting
次要结局
- Number of participants with clinically abnormal Vital signs(Up to Day 28)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Day 21)
- Number of participants with TEAEs(Up to Day 14)
- Time to first onset of nausea and vomiting(Up to Day 21)
- Time to resolution of first episode of nausea or vomiting(Up to Day 21)
- Number of participants with TEAEs(Up to Day 28)
- Number of participants with serious TEAEs(Up to Day 28)
- Number of participants with Adverse Events of Special Interests (AESIs)(Up to Day 28)
- Number of participants with TEAEs leading to discontinuation(Up to Day 28)
研究者
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