Assessments
ADVERSE EVENTS, ADVERSE EVENT
Primary endpoints were percentage of participants with ≥ 1 treatment-emergent adverse event (TEAE) and the percentage of participants meeting markedly abnormal criteria for clinical safety laboratory tests, vital signs, or 12-lead electrocardiography (ECG) at least once. Safety assessments included full physical examinations, vital signs, and 12-lead ECG—performed at screening, baseline, and during each treatment period—and monitoring of adverse events (AEs) throughout the study. AEs were coded by system organ class and preferred term using the Medical Dictionary for Regulatory Activities (MedDRA) version 23.0. A TEAE was defined for each treatment period as an AE with onset on or after the first dose of the study drug and before the first dose of study drug in the next treatment period. Pharmacokinetics were evaluated in all participants who received danavorexton; to do so, serial blood samples were collected before infusion and up to 24 h after infusion start.Exploratory endpoints included the effects of danavorexton on EDS as measured using the 40-min MWT [