Treatment-emergent Adverse Events Reported with Flubentylosin in Part 2 (Food Effect), presented by System-organ Class.
EVENTS
Subjects are counted only once in each row, regardless of how many events they experienced.During Period 1, Part 2 of the study, 2 subjects receiving flubentylosin under fasting conditions experienced asymptomatic and reversible Grade-1 elevated ALT and/or AST values. For those receiving flubentylosin under fed conditions, 2 subjects experienced AEs of asymptomatic and reversible elevated liver enzymes leading to discontinuation of the study drug: one subject had Grade-2 elevations of ALT at 131 U/L (normal range 0–35 U/L) and AST at 102 U/L (normal range 9–35 U/L) six days after receiving a single 1000-mg dose of flubentylosin, and one subject had Grade-4 elevations of ALT at 425 U/L (normal range 0–35 U/L) and AST at 453 U/L (normal range 9–35 U/L) three days after receiving a single 1000-mg dose of flubentylosin. No accompanying increases in total, direct, or indirect bilirubin were observed. The investigator considered the AEs to have a reasonable possibility of being related to flubentylosin. The food effect on exposure parameters, i.e. CIn Part 3 (MAD), 33.3% of flubentylosin-treated subjects and 30.0% of placebo-treated subjects experienced at least one TEAE (