3.3 Safety analysis
All the 20 subjects enrolled in this study completed 2 times of famitinib and 13 times of omeprazole administration as planned. A total of 9 (45.0%) subjects had 16 AEs, all of which were treatment-emergent adverse events (TEAEs) at grade 1 severity according to the Common Terminology Criteria for Adverse Events (CTCAE) guidelines. No adverse events of grade 2 or above were reported. Among the total 16 AEs, 9 TEAEs occurred in 6 subjects (30.0%) in the single administration phase of famitinib; 1 subject (5.0%) had 1 TEAE in the single administration phase of omeprazole; At the stage of famitinib combined with omeprazole, 5 subjects (25.0%) had 6 TEAEs. Famitinib was generally well tolerated when administered either alone or in combination with omeprazole.
A summary of the above TEAEs was shown in Table 3. 5 (25.0%) subjects had 10 TEAEs related to famitinib including alanine aminotransferase increased (10%), blood triglycerides increased (10%), gamma-glutamyl transferase increased (5%), basophil count increased (5%), white blood cells urine positive (5%), glucose urine present (5%), and blood glucose increased (5%). 2 (10.0%) subjects had 2 TEAEs related to omeprazole including gamma-glutamyl transferase increased (5%) and increased heart rate. All adverse events occurred during the study period were recovered / resolved at the end of the study.