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临床试验/NCT07063342
NCT07063342招募中1 期

Phase 1, 4-Part, Open-label (Parts 1 to 3) and Double-blind (Part 4) Study to Evaluate the Pharmacokinetics of Novel KarX (BMS-986519) and KarT (BMS-986520) Prototypes Versus the KarXT (BMS-986510) and KarX-EC (BMS-986519) Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants, and to Evaluate Alternative Formulations of KarX (BMS-986519) and KarXT (BMS-986510) Following Single and Multiple Ascending Doses in Healthy Adult Participants

Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2025年6月27日最近更新:
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干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
入组人数
236
试验地点
1
主要终点
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate novel KarX and KarT prototypes versus the KarXT and KarX-EC reference following single doses, to explore the effect of food after multiple doses of selected prototypes, and to evaluate alternative formulations of KarX and KarXT following single and multiple ascending doses in healthy adult participants.

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 55 Years（Adult）
性别
All
接受健康志愿者
是

入选标准

  • •BMI between 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
  • •Other protocol-defined Inclusion/

排除标准

  • 未提供

研究组 & 干预措施

Part 3a

Experimental

干预措施: Xanomeline/Trospium Chloride Capsule (Drug)

Part 3a

Experimental

干预措施: Xanomeline Enteric Capsule (Drug)

Part 3b

Experimental

干预措施: Xanomeline/Trospium Chloride Capsule (Drug)

Part 3b

Experimental

干预措施: Xanomeline Enteric Capsule (Drug)

Part 3b

Experimental

干预措施: Xanomeline MR (Drug)

Part 4a

Experimental

干预措施: Xanomeline/Trospium Chloride Capsule (Drug)

Part 4a

Experimental

干预措施: Placebo (Drug)

Part 4b

Experimental

干预措施: Xanomeline/Trospium Chloride Capsule (Drug)

Part 4b

Experimental

干预措施: Placebo (Drug)

Part 2

Experimental

干预措施: Xanomeline MR (Drug)

Part 4b

Experimental

干预措施: Xanomeline (Drug)

Part 4a

Experimental

干预措施: Xanomeline (Drug)

Part 1

Experimental

干预措施: Trospium Chloride (Drug)

Part 2

Experimental

干预措施: Xanomeline Enteric Capsule (Drug)

Part 1

Experimental

干预措施: Xanomeline/Trospium Chloride Capsule (Drug)

Part 1

Experimental

干预措施: Xanomeline Enteric Capsule (Drug)

Part 2

Experimental

干预措施: Xanomeline/Trospium Chloride Capsule (Drug)

结局指标

主要结局

Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

时间窗: Up to Day 23

Maximum observed concentration (Cmax)

时间窗: Up to Day 23

Time of maximum observed concentration (Tmax)

时间窗: Up to Day 23

Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

时间窗: Up to Day 23

Area under the concentration-time curve in 1 dosing interval (AUC(TAU))

时间窗: Up to Day 23

Concentration at the end of a dosing interval (Ctau)

时间窗: Up to Day 23

Apparent total body clearance (CLT/F)

时间窗: Up to Day 23

Effective elimination half-life during dosing interval (T-HALF(eff))

时间窗: Up to Day 23

Number of participants with Treatment Emergent Adverse Events (TEAEs)

时间窗: Up to 30 days after final dose of study intervention

Number of participants with Serious Adverse Events (SAEs)

时间窗: Up to 30 days after final dose of study intervention

Number of participants with Adverse Events of Special Interest (AESIs)

时间窗: Up to 30 days after final dose of study intervention

Number of participants with AEs leading to discontinuation

时间窗: Up to 30 days after final dose of study intervention

Columbia-Suicide Severity Rating Scale (C-SSRS)

时间窗: Up to Day 14

次要结局

  • Number of participants with Treatment Emergent Adverse Events (TEAEs)(Up to 30 days after final dose of study intervention)
  • Number of participants with Serious Adverse Events (SAEs)(Up to 30 days after final dose of study intervention)
  • Number of participants with Adverse Events of Special Interest (AESIs)(Up to 30 days after final dose of study intervention)
  • Number of participants with AEs leading to discontinuation(Up to 30 days after final dose of study intervention)
  • Number of participants with vital signs abnormalities(Up to 30 days after final dose of study intervention)
  • Number of participants with electrocardiogram (ECG) abnormalities(Up to 30 days after final dose of study intervention)
  • Number of participants with physical examination abnormalities(Up to 30 days after final dose of study intervention)
  • Number of participants with clinical laboratory abnormalities(Up to 30 days after final dose of study intervention)
  • Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to Day 25)
  • Geometric mean ratio of Cmax(Up to Day 23)
  • Geometric mean ratio of AUC(0-T)(Up to Day 23)
  • Geometric mean ratio of AUC(INF)(Up to Day 23)
  • Geometric mean ratio of area under the concentration-time curve in 1 dosing interval (AUC(TAU))(Up to Day 23)
  • Time of maximum observed concentration (Tmax)(Up to Day 16)
  • Geometric mean ratio of Cmax(Up to Day 12)
  • Geometric mean ratio of AUC(0-T)(Up to Day 12)
  • Geometric mean ratio of AUC(INF)(Up to Day 12)
  • Geometric mean ratio of area under the concentration-time curve in 1 dosing interval (AUC(TAU))(Up to Day 12)
  • Maximum observed concentration (Cmax)(Up to Day 16)
  • Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))(Up to Day 16)
  • Area under the plasma concentration-time curve from time zero to 12 hours (AUC(0-12))(Up to Day 4)
  • Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))(Up to Day 23)
  • Apparent total body clearance (CLT/F)(Up to Day 16)
  • Area under the concentration-time curve in 1 dosing interval (AUC(TAU))(Up to Day 16)
  • Effective elimination half-life during dosing interval (T-HALF(eff))(Up to Day 16)
  • Cmax Accumulation Index: Ratio of Cmax at steady state to Cmax after first dose (AI_Cmax)(Up to Day 16)
  • AUC(TAU) Accumulation Index: Ratio of AUC(TAU) at steady state to AUC(TAU) after first dose (AI_AUC)(Up to Day 16)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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