A Study of LY3873862 in Participants With Sporadic or Familial Amyotrophic Lateral Sclerosis (ALS).
2026年11月12日 更新者：Eli Lilly and Company
A Phase 1b, Randomized, Placebo-Controlled, Participant and Investigator-Blinded, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Cytochrome P450 Interaction of Orally Administered LY3873862 in Participants With Sporadic or Familial Amyotrophic Lateral Sclerosis
The main purpose of this study in participants with Sporadic or Familial Amyotrophic Lateral Sclerosis (ALS) is to test the safety of different doses and to determine the amount of LY3873862 that gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last up to approximately 13 weeks and will include 6 clinic visits.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
32
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。
学习联系方式
- 姓名：Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- 电话号码：1-317-615-4559
- 邮箱：LillyTrials@Lilly.com
研究联系人备份
- 姓名：Physicians interested in becoming principal investigators please contact
- 邮箱：clinical_inquiry_hub@lilly.com
学习地点
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Montreal、加拿大、H3A 2B4
- Montreal Neurological Institute and Hospital
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首席研究员：
- Angela Genge
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接触：
- 电话号码：514-449-8741
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Toronto、加拿大、M4N 3M5
- Sunnybrook Health Sciences Centre
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首席研究员：
- Agessandro Abrahao
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接触：
- 电话号码：(416) 480-6100 x687561
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California
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San Francisco、California、美国、94109
- Sutter Health Research Institute- California Pacific Medical Center, Van Ness Campus
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首席研究员：
- Jonathan Katz
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接触：
- 电话号码：(415) 600-3604
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Colorado
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Aurora、Colorado、美国、80045
- University of Colorado Anschutz
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首席研究员：
- Laura Foster
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District of Columbia
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Washington D.C.、District of Columbia、美国、20007
- Georgetown University Medical Center
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首席研究员：
- Shakti Nayar
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern University
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首席研究员：
- Senda Ajroud-Driss
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接触：
- 电话号码：312-503-0671
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Massachusetts
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Boston、Massachusetts、美国、02114
- Healey and AMG Center for ALS at Mass General Hospital
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首席研究员：
- Doreen Ho
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接触：
- 电话号码：617-724-3914
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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 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Have a diagnosis of sporadic or familial Amyotrophic Lateral Sclerosis (ALS) (definite, probable, laboratory probable) made by physician experienced with management of ALS as defined by the World Federation of Neurology revised El Escorial criteria.
- Have an ALS symptom onset as determined by the investigator within 24 months of screening.
- Have a body mass index within the range 18 to 35 kilograms per square meter (kg/m²) (inclusive).
- Are individuals assigned male at birth (AMAB) or assigned female at birth (AFAB), including both individuals of childbearing potential (IOCBP) and individuals not of childbearing potential (INOCBP). Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Are able to safely swallow solids or liquids, or both.
Exclusion Criteria:
- Have a history or presence of medical illness that, in the judgment of the investigator, indicates a medical problem that would preclude study participation including, but not limited to cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological, endocrine, psychiatric, neurologic, convulsions, or any clinically significant laboratory abnormality.
- Have a history of another neurodegenerative disease or significant dementia/severe cognitive problems at screening.
- Have a slow vial capacity (SVC) less than (<) 50% predicted value (for sex, age, ethnic origin, and height) at screening.
- Have significant hepatic abnormalities (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times (×) upper limit of normal (ULN) or total bilirubin (TBL) >1.5× ULN, in asymptomatic individuals with a history of Gilbert's syndrome, use TBL of >2× ULN).
- Have a significant renal impairment (estimated glomerular filtration rate less than 60 milliliters per minute per 1.73 square meters (eGFR<60 mL/min/1.73m²)).
- If taking riluzole, must be on a stable dose for more than 30 days (prior to Day 1).
- If taking intravenous or oral edaravone, must have completed 2 treatment cycles (prior to Day 1).
- Are currently taking or plan to take tofersen for the duration of the study.
- Show evidence of Human Immunodeficiency Virus (HIV) and/or positive human HIV antibodies.
- Show evidence of hepatitis B and/or positive hepatitis B surface antigen.
- Have a positive Hepatitis C Virus (HCV) antibody test. Participants with a positive HCV antibody test at screening can be included only if a confirmatory HCV Ribonucleic Acid (RNA) test is negative.
- Have an abnormal blood pressure judged to be clinically significant by the investigator.
- Have a history of clinically significant back pain, pathological conditions of the back, or back injury (for example, degenerative disease, spinal deformity, or spinal surgery), have a local infection at the intended site of the lumbar puncture (LP) that may predispose to complications or technical difficulty with LP.
- Are taking or intend to take inhibitors or inducers of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 from 14 days prior to the first dose of any study intervention, or for 5 half lives (whichever is longer), until the final PK sample is collected.
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：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：LY3873862 or Placebo (Cohort 1)
LY3873862 or placebo administered orally |
Administered orally Administered orally |
|
实验性的：LY3873862 or Placebo (Cohort 2)
LY3873862 or placebo administered orally with a CYP450 drug cocktail |
Administered orally Administered orally CYP450 Drug Cocktail (caffeine, midazolam, flurbiprofen, dextromethorphan and omeprazole) administered orally. |
|
实验性的：LY3873862 or Placebo (Cohort 3)
LY3873862 or placebo administered orally with a CYP450 drug cocktail |
Administered orally Administered orally CYP450 Drug Cocktail (caffeine, midazolam, flurbiprofen, dextromethorphan and omeprazole) administered orally. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Number of Patients with One or More Treatment Emergent Adverse Events Considered by the Investigator to be Related to Study Drug Administration
大体时间：Baseline, Day 28
|
Baseline, Day 28
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3873862
大体时间：Baseline, Day 7
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Baseline, Day 7
|
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Pharmacokinetics: Maximum Concentration (Cmax) of LY3873862
大体时间：Baseline, Day 7
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Baseline, Day 7
|
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。
调查人员
- 研究主任：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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 (估计的)
2026年11月1日
初级完成 (估计的)
2027年11月1日
研究完成 (估计的)
2027年11月1日
研究注册日期
首次提交
2026年10月14日
首先提交符合 QC 标准的
2026年10月14日
首次发布 (实际的)
2026年10月20日
研究记录更新
最后更新发布 (实际的)
2026年11月13日
上次提交的符合 QC 标准的更新
2026年11月12日
最后验证
2026年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.