A Study of LY3873862 in Participants With Sporadic or Familial Amyotrophic Lateral Sclerosis (ALS).
12. november 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
32
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Telefonnummer: 1-317-615-4559
- E-mail: LillyTrials@Lilly.com
Undersøgelse Kontakt Backup
- Navn: Physicians interested in becoming principal investigators please contact
- E-mail: clinical_inquiry_hub@lilly.com
Studiesteder
-
-
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Montreal, Canada, H3A 2B4
- Montreal Neurological Institute and Hospital
-
Ledende efterforsker:
- Angela Genge
-
Kontakt:
- Telefonnummer: 514-449-8741
-
Toronto, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
Ledende efterforsker:
- Agessandro Abrahao
-
Kontakt:
- Telefonnummer: (416) 480-6100 x687561
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-
-
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California
-
San Francisco, California, Forenede Stater, 94109
- Sutter Health Research Institute- California Pacific Medical Center, Van Ness Campus
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Ledende efterforsker:
- Jonathan Katz
-
Kontakt:
- Telefonnummer: (415) 600-3604
-
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado Anschutz
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Ledende efterforsker:
- Laura Foster
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20007
- Georgetown University Medical Center
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Ledende efterforsker:
- Shakti Nayar
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
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Ledende efterforsker:
- Senda Ajroud-Driss
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Kontakt:
- Telefonnummer: 312-503-0671
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Healey and AMG Center for ALS at Mass General Hospital
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Ledende efterforsker:
- Doreen Ho
-
Kontakt:
- Telefonnummer: 617-724-3914
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: LY3873862 or Placebo (Cohort 1)
LY3873862 or placebo administered orally |
Administered orally Administered orally |
|
Eksperimentel: 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. |
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of Patients with One or More Treatment Emergent Adverse Events Considered by the Investigator to be Related to Study Drug Administration
Tidsramme: Baseline, Day 28
|
Baseline, Day 28
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3873862
Tidsramme: Baseline, Day 7
|
Baseline, Day 7
|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY3873862
Tidsramme: Baseline, Day 7
|
Baseline, Day 7
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: 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
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. november 2026
Primær færdiggørelse (Anslået)
1. november 2027
Studieafslutning (Anslået)
1. november 2027
Datoer for studieregistrering
Først indsendt
14. oktober 2026
Først indsendt, der opfyldte QC-kriterier
14. oktober 2026
Først opslået (Faktiske)
20. oktober 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 27886
- J3X-MC-LYGD (Anden identifikator: Eli Lilly and Company)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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