This first-in-human, double-blind, placebo-controlled Phase I study will be conducted in participants with amyotrophic lateral sclerosis (ALS) to explore safety, tolerability, and pharmacokinetic (PK) properties of GDC-0134. It will include three components: a Single-Ascending-Dose (SAD) stage, a Multiple-Ascending-Dose (MAD) stage, and an Open-Label Safety Expansion (OSE) stage.
In the experimental arm of the study, participants in multiple cohorts and treatment periods will receive single doses of GDC-0134 under fed/fasting conditions. In the placebo arm, participants in multiple cohorts and treatment periods will receive single doses of placebo under fed/fasting conditions.
18 years and older; both genders; no healthy volunteers, Currently taking edaravone unless after completion of at least the second 14-day drug-treatment period, as long as Day 1 occurs during a drug-free period at least 24 hours after the last edaravone dose and at least 5 days prior to the first dose of the next cycle