Study assessments and endpoints
jaundice, pre‐dose
ADVERSE EVENTS, BLOOD
The primary objective of this study was to evaluate the PK, safety, and tolerability of selnoflast. The main endpoints were the incidence and severity of adverse events (AEs), changes in vital signs, 12‐lead electrocardiogram (ECG) parameters, and clinical laboratory safety parameters. AEs were monitored throughout the study and at the 14‐day follow‐up visit. Safety assessments included recording of the incidence and type of treatment‐emergent adverse events (TEAEs), discontinuations, serious TEAEs, and adverse events of special interest (AESIs) (including cases of elevated alanine aminotransferase [ALT] or aspartate aminotransferase [AST] in combination with either elevated bilirubin or clinical jaundice). Vital signs, ECGs, blood chemistry and hematology panels, coagulation panels and urinalysis were assessed at screening and at various time points during the study. Changes in absolute lymphocyte count were also assessed. Blood samples for PK analyses were obtained pre‐dose and at various timepoints up to 24 h post‐dose throughout the 7‐day in‐clinic treatment period, as well as once during the 14‐day follow‐up visit. As the 1‐week duration of the study was too short for assessing clinical changes, no clinical assessments were planned. Further details are given in the study protocol (