NCT07061288招募中1 期
An Open-label, Phase 1, Dose-Finding Study to Characterize the Safety, Tolerability, and Pharmacokinetics of a Long-Acting Injectable KarXT Formulation in Participants With Schizophrenia
Bristol-Myers Squibb16 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2025年9月3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
- 招募中
- 发起方
- 入组人数
- 131
- 试验地点
- 16
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have a primary diagnosis of schizophrenia, as confirmed by psychiatric evaluation based on Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) criteria and Mini International Neuropsychiatric Interview (MINI) (version 7.0.2).
- •Participants must have a Positive and Negative Syndrome Scale (PANSS) total score ≤ 80 and a Clinical Global Impression - Severity (CGI-S) score ≤ 4 at both screening and baseline.
- •Participants must have a body mass index (BMI) between 18 and 40 kg/m².
- •Participants should be willing and able, as determined by the investigator, to discontinue all antipsychotic medications prior to the baseline visit and must be able to comply with all protocol requirements.
排除标准
- •Participants must not have newly diagnosed schizophrenia or a first treated episode of schizophrenia.
- •Participants must not have any other DSM-5-TR disorder diagnosed within the past 12 months, such as major depressive disorder or bipolar disorder.
- •Participants must not have a history of alcohol or drug use disorder within the past 12 months or those with clinically significant disease or disorder that would jeopardize their safety or affect the validity of study results.
- •Participants must not be at risk for suicidal behavior.
- •Female participants must not be pregnant or breastfeeding.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Administration of KarXT
Experimental
干预措施: KarXT (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Up to 3 weeks
Number of participants with adverse events of special interest (AESIs)
时间窗: Up to 3 weeks
Number of participants with serious adverse events (SAEs)
时间窗: Up to 3 weeks
次要结局
- Maximum concentration (Cmax)(Up to 15 weeks)
- Time to maximum concentration (Tmax)(Up to 15 weeks)
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))(Up to 15 weeks)
- Area under the plasma concentration-time curve from time zero to infinity (AUC(INF))(Up to 15 weeks)
- Area under the plasma concentration-time curve from time zero to 672 hours (AUC(0-672))(Up to 15 weeks)
- Apparent terminal phase half-life (T-HALF)(Up to 15 weeks)
- Apparent total body clearance (CLT/F)(Up to 15 weeks)
- Apparent volume of distribution of terminal phase (Vz/F)(Up to 15 weeks)
- Number of participants with AEs(Up to 3 weeks)
- Number of participants with AESIs(Up to 3 weeks)
- Number of participants with SAEs(Up to 3 weeks)
研究者
研究点 (16)
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