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LY3502970 在健康参与者中的多剂量研究

2026年4月30日更新者：Eli Lilly and Company

在健康参与者中进行的多剂量研究，以研究 LY3502970 的安全性、耐受性和药代动力学

本研究的主要目的是评估与参比 LY3502970 制剂相比，LY3502970 以新制剂多次口服给药时进入血流的速度有多快以及身体将其清除需要多长时间。将收集有关安全性和耐受性的信息。该研究对健康参与者开放。该研究分两部分进行，将持续长达约 6 个月，包括筛选期。

研究概览

地位

完全的

条件

健康

干预/治疗

研究类型

介入性

注册 (实际的)

阶段

阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

英国
- - Nottingham、英国、NG11 6JS
    - Quotient Clinical Ltd

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年至 65年 (成人、年长者)

接受健康志愿者

是的

描述

纳入标准：

经医学评估确定为明显健康。
体重指数 (BMI) 为 18.5 至 35 公斤每平方米 (kg/m²)。

排除标准：

有研究者确定的异常血压和/或脉率 - 允许研究者可接受的微小偏差
已知有肝病、明显的肝病临床体征或症状、急性或慢性肝炎，或转氨酶（丙氨酸转氨酶 [ALT] 和天冬氨酸转氨酶 [AST]）升高超过 2X ULN（正常上限）
在筛选时 12 导联心电图出现异常，研究者认为这会增加参与研究的相关风险
女性是否具有生育潜力
是哺乳期的女性吗

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：基础科学
分配：随机化
介入模型：交叉作业
屏蔽：单身的

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：Part A Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received single escalating doses of LY3502970 oral capsule every 6 days, starting with a dose of 2 milligrams (mg), increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19. Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 reference oral capsule once daily (QD) Test Phase/Fasted state (Day 25 to Day 36): On Day 25, participants were randomly assigned to receive 16 mg of LY3502970 QD, either as Prototype 1 tablet or Prototype 2 tablet, and continued through Day 30 (Test Phase 1). On Day 31, participants crossover to the other prototype formulation (i.e., those who initially received prototype 1 now receive prototype 2, and vice versa), continuing through Day 36 (Test Phase 2).	药品：LY3502970 口服给药。
实验性的：Part B Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received single escalating doses of LY3502970 oral capsule every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19. Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 prototype 2 tablet QD. Test Phase 1/Fed state (Day 25 to Day 30): During this phase, participants were administered 16 mg of LY3502970 prototype 2 tablet QD. Test Phase 2/Fasted state (Day 31 to Day 36): During this phase, participants were administered a PPI 40 mg Esomeprazole tablet first, followed by 16 mg of LY3502970 prototype 2 tablet QD. The PPI was administered to elevate gastric pH (potential of hydrogen), and PK (pharmacokinetic) parameters were evaluated under these elevated gastric pH conditions	药品：LY3502970 口服给药。药品：埃索美拉唑口服给药。

参与者组/臂

干预/治疗

实验性的：Part A

Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received single escalating doses of LY3502970 oral capsule every 6 days, starting with a dose of 2 milligrams (mg), increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19.
Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 reference oral capsule once daily (QD)
Test Phase/Fasted state (Day 25 to Day 36): On Day 25, participants were randomly assigned to receive 16 mg of LY3502970 QD, either as Prototype 1 tablet or Prototype 2 tablet, and continued through Day 30 (Test Phase 1). On Day 31, participants crossover to the other prototype formulation (i.e., those who initially received prototype 1 now receive prototype 2, and vice versa), continuing through Day 36 (Test Phase 2).

药品：LY3502970

口服给药。

实验性的：Part B

Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received single escalating doses of LY3502970 oral capsule every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19.
Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 prototype 2 tablet QD.
Test Phase 1/Fed state (Day 25 to Day 30): During this phase, participants were administered 16 mg of LY3502970 prototype 2 tablet QD.
Test Phase 2/Fasted state (Day 31 to Day 36): During this phase, participants were administered a PPI 40 mg Esomeprazole tablet first, followed by 16 mg of LY3502970 prototype 2 tablet QD. The PPI was administered to elevate gastric pH (potential of hydrogen), and PK (pharmacokinetic) parameters were evaluated under these elevated gastric pH conditions

药品：LY3502970

口服给药。

药品：埃索美拉唑

口服给药。

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Part A: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation 大体时间：Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)	Part A: Cmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).	Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
Part A: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-Dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation 大体时间：Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)	Part A: AUC(0-24) of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).	Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation 大体时间：Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)	Part A: Tmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following: 16 mg reference capsule on Day 24, 16 mg Prototype 1 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2), and 16 mg Prototype 2 tablet administered on Day 30 (last/sixth dose of Test Phase 1) and Day 36 (last/sixth dose of Test Phase 2).	Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation 大体时间：Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)	Part B: Cmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.	Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
Part B: PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours Post-dose (AUC(0-24)) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation 大体时间：Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)	Part B: AUC(0-24) of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.	Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)
Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation 大体时间：Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)	Part B: Tmax of LY3502970 following the multiple administrations (i.e., last/sixth dose) of prototype formulations and the reference formulation. This includes the following:16 mg prototype 2 tablet (Fasted) on Day 24, 16 mg prototype 2 tablet (Fed) administered on Day 30 and 16 mg Prototype 2 tablet + PPI (Fasted) administered on Day 36.	Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Eli Lilly and Company

合作者

Quotient Sciences

调查人员

研究主任：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年9月16日

初级完成 (实际的)

2022年4月4日

研究完成 (实际的)

2022年4月4日

研究注册日期

首次提交

2021年9月16日

首先提交符合 QC 标准的

2021年9月16日

首次发布 (实际的)

2021年9月21日

研究记录更新

最后更新发布 (实际的)

2026年5月29日

上次提交的符合 QC 标准的更新

2026年4月30日

最后验证

2026年4月15日

LY3502970 在健康参与者中的多剂量研究

在健康参与者中进行的多剂量研究，以研究 LY3502970 的安全性、耐受性和药代动力学

研究概览

地位

条件

干预/治疗

研究类型

注册 (实际的)

阶段

联系人和位置

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

合作者和调查者

赞助

合作者

调查人员

研究记录日期

研究主要日期

学习开始 (实际的)

初级完成 (实际的)

研究完成 (实际的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

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