临床试验/NCT06379958

NCT06379958招募中1 期

A Phase 1, Open-label, 4-Part, Drug-Drug Interaction Study to Evaluate the Effects of Inhibition and Induction of CYP3A4 on the Pharmacokinetics of Leramistat, to Assess the Effect of Leramistat on the Pharmacokinetics of Simvastatin, and to Evaluate the Pharmacokinetic Interaction Between Leramistat and Upadacitinib (RINVOQ®) in Healthy Adult Subjects

Modern Biosciences Ltd1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2024年4月8日最近更新: 2024年8月9日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: Modern Biosciences Ltd
入组人数: 48
试验地点: 1
主要终点: leramistat:Elimination rate constant -Kel

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

A DDI study consisting of 4 parts conducted as an open label, fixed sequence study in healthy adult subjects.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Other
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

•Healthy, adult, male or female of non childbearing potential 18 to 55 years of age.

排除标准

•History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
•History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.

研究组 & 干预措施

Part 2: Phenytoin 100mg

Active Comparator

干预措施: leramistat 40mg (Drug)

Part 1: Itraconazole 200mg

Active Comparator

干预措施: leramistat 40mg (Drug)

Part 1: Itraconazole 200mg

Active Comparator

干预措施: Itraconazole 200 mg (Drug)

Part 2: Phenytoin 100mg

Active Comparator

干预措施: Phenytoin 100 Mg Oral Capsule (Drug)

Part 3: Simvastatin 40mg

Active Comparator

干预措施: leramistat 40mg (Drug)

Part 3: Simvastatin 40mg

Active Comparator

干预措施: Simvastatin 40mg (Drug)

Part 4: Upadacitinib 15 mg

Active Comparator

干预措施: leramistat 40mg (Drug)

Part 4: Upadacitinib 15 mg

Active Comparator

干预措施: Upadacitinib 15 MG (Drug)

结局指标

主要结局

leramistat:Elimination rate constant -Kel

时间窗: 8.5 weeks

leramistat: Area under the curve - AUC0-24h

时间窗: 8.5 Weeks

leramistat: Area under the curve - AUC0-t

时间窗: 8.5 Weeks

leramistat: Plasma Clearance -CL/F

时间窗: 8.5 weeks

leramistat: Volume of distribution - Vz/F

时间窗: 8.5 weeks

leramistat: Area under the curve - AUC0-inf

时间窗: 8.5 weeks

leramistat: Maximum observed concentration - Cmax

时间窗: 8.5 weeks

leramistat: Time of the maximum observed concentration - Tmax

时间窗: 8.5 weeks

leramistat: Half life - t½

时间窗: 8.5 weeks

次要结局

Incidence of adverse event.(8.5 weeks)

研究者

发起方

Modern Biosciences Ltd

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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