Safety and tolerability
nausea, diarrhea, abdominal pain, TEAEs, headache, dysgeusia, deaths, SAD
ADVERSE EVENTS, EVENTS, ADVERSE EVENT
There were no serious adverse events (AEs), deaths, or other significant AEs reported in the study.In the single ascending dose (SAD) period of the study, 18 (56.3%) of 32 subjects receiving ceftibuten reported a treatment emergent adverse event (TEAE), and 4 (50%) of 8 subjects reported five events in the pooled placebo group. Overall, the most frequently reported TEAEs in the 32 subjects in the total ceftibuten group were: headache, 9 events reported in 7 (21.9%) subjects; dysgeusia, 4 events reported in 3 (9.4%) subjects; and nausea, 4 events reported in 4 (12.5%) subjects. All TEAEs were mild or moderate in severity. No subjects discontinued from the study during the SAD period of the study.In the multiple ascending dose (MAD) period of the study, 22 (68.8%) of 32 subjects that received ceftibuten reported 65 TEAEs compared to 3 (37.5%) of 8 subjects that reported 9 events in the pooled placebo group. Overall, the most frequently reported TEAEs in the 32 subjects that received ceftibuten were: headache, 14 events reported in 8 (25%) subjects; nausea, abdominal pain and diarrhea, each with 4 events reported in 4 (12.5%) subjects; and upper abdominal pain and dysgeusia, each with 3 events reported in 3 (9.4%) subjects (Treatment emergent adverse events observed in three or more subjects receiving ceftibuten during the multiple ascending dose period of the study
Alanine aminotransferase (ALT) elevations were all mild in severity, asymptomatic, not associated with bilirubin elevations, and resolved following cessation of treatment and were observed in 1 (12.5%) of 8 subjects in the 400 mg ceftibuten group, 3 (37.5%) of 8 subjects in the 600 mg group, and 6 (37.5%) of 16 subjects in the 800 mg ceftibuten group.No clinically significant trends were observed in other chemistry data, hematology, coagulation, urinalysis, vital signs, or electrocardiograms.