NCT06853171已完成1 期
An Open-label, Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders
Bristol-Myers Squibb4 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年4月29日最近更新:
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
- 24
- 试验地点
- 4
- 主要终点
- Number of participants with Adverse Events (AEs)
研究概览
简要总结
This study is designed to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses and ratios of xanomeline and trospium chloride in an IR capsule (KarXT) and dual-burst release of xanomeline with immediate-release trospium chloride in adolescents with psychiatric disorders.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •LAR (ie, legal guardian or caregiver) must have signed and dated an IRB/IEC-approved ICF in accordance with regulatory, local, and institutional guidelines.
- •Confirmed Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) psychiatric diagnosis of 1 of the following:
- •Schizophrenia or schizoaffective disorder
- •Bipolar I or II disorder
- •Attention-deficit/hyperactivity disorder (ADHD)
- •Tourette's disorder
- •Autism spectrum disorder (ASD)
- •Participant is judged by the investigator to be clinically stable (eg, no psychiatric hospitalization within the last 6 months; no imminent risk of suicide or injury to self, others, or property).
排除标准
- •Any clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, GI (including active obstructive GI disorders), carcinoma, active biliary disorders (eg, symptomatic gallstones) and/or urological disorder, congestive heart failure (uncontrolled), or CNS infection that would pose a risk to the participants if they were to participate in the study or that might confound the results of the study.
- •Participant has a risk for suicidal behavior during the study, as determined by the investigator's clinical judgment and C-SSRS.
- •eGFR < 60 mL/min.
- •History of Gilbert's Disease or history of liver disease (Child-Pugh class A and higher).
- •History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
- •Participants with history of bladder stones or recurrent UTIs.
- •Other protocol defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Cohort 1
Experimental
干预措施: KarXT (Drug)
Cohort 2
Experimental
干预措施: KarXT (Drug)
Cohort 2
Experimental
干预措施: KarX-EC (Drug)
Cohort 3
Experimental
干预措施: KarXT (Drug)
Cohort 3
Experimental
干预措施: KarX-EC (Drug)
结局指标
主要结局
Number of participants with Adverse Events (AEs)
时间窗: Up to Day 43
Number of participants with Serioues AEs (SAEs)
时间窗: Up to Day 43
Number of participants with AEs of Special Interest (AESIs)
时间窗: Up to Day 43
次要结局
- Maximum observed plasma concentration (Cmax)(Up to Day 15)
- Area under the concentration-time curve in 1 dosing interval (AUC(TAU))(Up to Day 15)
- AUC accumulation index (AI_AUC)(Up to Day 15)
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))(Up to Day 15)
- Time of maximum observed plasma concentration (Tmax)(Up to Day 15)
- Concentration at the end of a dosing interval (Ctau)(Up to Day 15)
- Cmax accumulation index (AI_Cmax)(Up to Day 15)
- Ctau accumulation index (AI_Ctau)(Up to Day 15)
- Average concentration within a dosing interval at steady-state (Css-avg)(Up to Day 15)
- Apparent total body clearance (CLT/F)(Up to Day 15)
- Effective elimination half-life during dosing interval (T-HALF(eff))(Up to Day 15)
- T-HALFeff based on AUC observed (T-HALFeff_AUC)(Up to Day 15)
研究者
研究点 (4)
Loading locations...
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