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

Eli Lilly and Company

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

Age range: 18–75 years
Sex: All
Healthy volunteers: No

Detailed criteria

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 potentia…

Interventions

Drug
LY3873862
Administered orally
Drug
CYP450 Drug Cocktail
CYP450 Drug Cocktail (caffeine, midazolam, flurbiprofen, dextromethorphan and omeprazole) administered orally.
Drug
Placebo
Administered orally

Summary

Eligibility

Interventions

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