A Phase 1, 3-part, Open-label Study to Evaluate the Effects of KarXT Administration on the Pharmacokinetics of Midazolam, Fexofenadine, and Digoxin in Healthy Adult Participants

Karuna Therapeutics, Inc., a Bristol Myers Squibb company1 个研究点分布在 1 个国家目标入组 62 人开始时间: 2025年9月29日最近更新: 2026年7月22日

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 62
试验地点: 1
主要终点: Part 2: GMR of Cmax of fexofenadine with and without KarXT

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 the effects of KarXT administration on the drug levels of midazolam, fexofenadine, and digoxin in healthy adult participants.

研究设计

研究类型: Interventional
分配方式: Non 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 50 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•Participants must be healthy male and female (INOCBP) as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, VS, and clinical laboratory determinations.
•Participants must have BMI of 18.0 to 32.0 kg/m2.

排除标准

•Participants must not have organ dysfunction or any clinically significant deviation from normal in physical examination, VS, ECG, or clinical laboratory determinations beyond what is consistent with the target population reference ranges.
•Participants must not have cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on the LFT results.
•Participants must not have any other significant acute or chronic medical illness, as assessed by the investigator.
•Participants must not have history or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia.
•Participants must not have current or recent (within 3 months of first study intervention administration) GI disease that could possibly affect drug ADME (eg, bariatric procedure).
•Participants must not have any major surgery, including GI surgery (eg, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).
•Participants must not have history of active GI obstructive disorder.
•Participants must not have history of bladder stones.
•Participants must not have history of recurrent urinary tract infections.
•Other protocol-defined Inclusion/Exclusion criteria apply.

研究组 & 干预措施

Part 3

Experimental

干预措施: KarXT (Drug)

Part 3

Experimental

干预措施: Digoxin (Drug)

Part 1

Experimental

干预措施: Midazolam (Drug)

Part 2

Experimental

干预措施: KarXT (Drug)

Part 1

Experimental

干预措施: KarXT (Drug)

Part 1a

Experimental

干预措施: KarXT (Drug)

Part 2

Experimental

干预措施: Fexofenadine (Drug)

Part 1a

Experimental

干预措施: Midazolam (Drug)