Safety and tolerability
ADVERSE EVENTS
Luvadaxistat was well tolerated, and all adverse events (AEs) were of mild intensity and not related to treatment. No serious AEs occurred. Clinical laboratory values were within normal limits for most subjects throughout the study. Three subjects following placebo treatment had a markedly abnormal laboratory value (bilirubin, creatinine, and glucose; one subject each [3.8%]), and one subject (7.1%) following luvadaxistat 500 mg treatment had a markedly abnormal creatinine value. The subject with the markedly abnormal creatinine value had a high pre-dose value of 3.15 mg/dL on day −2. The subject was brought back for a retest (unscheduled visit) 2 days later, and the creatinine value was normal (0.95 mg/dL). The subject also had other pre- and post-dose measurements that were within normal ranges; therefore, the abnormal value was not considered clinically significant.