A randomized, single-dose, crossover study of the effects of ulotaront on electrocardiogram intervals in subjects with schizophrenia.

ABSTRACT: This study (NCT04369391) evaluated the effects of ulotaront (SEP-363856), a novel trace amine-associated receptor 1 (TAAR1) agonist in development for schizophrenia, on electrocardiogram parameters. Study design was a randomized, single-dose, three-period crossover (ulotaront 150 mg, placebo, moxifloxacin 400 mg). Sixty subjects with schizophrenia completed all periods. Ulotaront had no clinically relevant effect on heart rate, PR interval, or QRS duration. In by-time-point analysis (secondary analysis), the upper bound of the two-sided 90% confidence interval for ΔΔQTcF (QT interval corrected for heart rate using Fridericia's formula) was below 10 ms at all time points for ulotaront. In concentration-QTc analysis (primary analysis), a linear mixed-effects model with ulotaront and its majo

SUBMITTER: Tsukada H 

PROVIDER: S-EPMC10264939 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature