Ireland
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Starting soon Phase 1

A Study of LY3873862 in Participants With Sporadic or Familial Amyotrophic Lateral Sclerosis (ALS).

NCT07883590 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2026-11
Last updated
2026-10-20

Condition(s) studied

Amyotrophic Lateral SclerosisCytochrome P-450 Enzyme System

Investigational drug(s) / intervention(s)

LY3873862CYP450 Drug CocktailPlacebo

LY3873862: Administered orally

CYP450 Drug Cocktail: CYP450 Drug Cocktail (caffeine, midazolam, flurbiprofen, dextromethorphan and omeprazole) administered orally.

Placebo: Administered orally

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of Patients with One or More Treatment Emergent Adverse Events Considered by the Investigator to be Related to Study Drug Administration — Baseline, Day 28

Trial sites (4)

FacilityCityRegionStatus
Sutter Health Research Institute- California Pacific Medical Center, Van Ness Campus San Francisco California
University of Colorado Anschutz Aurora Colorado
University of Kansas Medical Center Kansas City Kansas
McGill University Montreal Canada
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07883590 on ClinicalTrials.gov ↗ ← All trials in the USA