Study of LY3873862 and CYP450 Drug Cocktail in Patients with ALS
A Phase 1 interventional study planned to enroll 32 participants with sporadic or familial ALS, assessing the safety and pharmacokinetics of the drug LY3873862 and a drug cocktail. The primary endpoint was to track any treatment-emergent adverse events related to the drug. No results have been reported yet.
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- #MSResearch
- Most relevant to
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- Source
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- Human efficacy
- Not established from this source
- Mechanism
- Not reported
- Evidence strength
- No results yet
- Outcome
- Not reported
Why it matters
Understanding the safety and pharmacokinetics of LY3873862 is crucial for future ALS treatments. The study aims to gauge the drug's potential effectiveness and tolerability before moving to further phases.
What this does not prove
No results are posted; planned enrollment and endpoints do not constitute findings, which limits the assessment of study outcomes.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- 32 · planned enrolment
- Randomised
- Yes
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
- Biological target
- LY3873862, CYP450 Drug Cocktail
- Pathway
- Not reported
- Population
- participants with sporadic or familial Amyotrophic Lateral Sclerosis (ALS); ages from 18 Years to 75 Years; sex All
- Size of effect
- Not reported
- Secondary endpoints
- Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3873862; Pharmacokinetics: Maximum Concentration (Cmax) of LY3873862
- MRI endpoints
- Not reported
- Biomarkers
- Not reported
- Safety
- Not reported
Original sources
Supporting passages (16)
study phasePhase: Phase 1
study designStudy type: Interventional
subjectsParticipants: people; ages from 18 Years to 75 Years; sex All
sample sizeEnrollment: 32 participants (estimated)
randomizedAllocation: Randomized
limitationsPlanned enrolment and endpoints are not findings.
biological targetsInterventions: LY3873862; CYP450 Drug Cocktail; Placebo
population"briefSummary": "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.
secondary endpoints"measure": "Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3873862",
findingsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
peer reviewedTrial registry record.
controlledIntervention model: Parallel Arm types: Experimental; Experimental; Experimental
primary endpointPrimary endpoints: Number of Patients with One or More Treatment Emergent Adverse Events Considered by the Investigator to be Related to Study Drug Administration
interventionInterventions: LY3873862; CYP450 Drug Cocktail; Placebo
follow upFollow-up: Baseline, Day 28; Baseline, Day 7
sample size basisEnrollment: 32 participants (estimated)
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