Study design
This was a phase 1b, randomized, double-blind, placebo-controlled, two-period, two-treatment crossover study of a single IV infusion of danavorexton in adults with IH. The study was conducted between January 2020 and November 2020 in the United States and Japan (NCT04091438), and consisted of a 28-day screening period, two 1-day treatment periods separated by a 1-day washout period, and a 1-week follow-up period. A 1-day washout period was selected for this study based on pharmacokinetic findings from previous research, which indicated a short half-life and return of pharmacokinetic and physiologic responses to pre-dose levels within 24 h [