TABLE 5.

Summary of AEs under different dosing regimens and dosing conditions^a

Parameter	Value for:
	Multiple ascending dose study			Food effect study	All subjects
	3 mg/kg	7.5 mg/kg	15 mg/kg
Total no. of subjects	8	8	8	12	36
≥1 AE	3 (38)	3 (38)	2 (25)	3 (25)	11 (31)
≥1 AE related to study drug	3 (38)	3 (38)	1 (13)	2 (17)	9 (25)
Mild (grade 1)	3 (38)	3 (38)	1 (13)	2 (17)	9 (25)
Moderate (grade 2)	0 (0)	1 (13)	0 (0)	0 (0)	1 (3)
Severe (grade 3)	0 (0)	0 (0)	0 (0)	0 (0)	0 (0)
Study drug-related AEs by MedDRA system organ class	3 (38)	3 (38)	2 (25)	3 (25)	11 (31)
Nervous system disorders	2 (25)	2 (25)	1 (13)	0 (0)	5 (14)
Gastrointestinal disorders	0 (0)	2 (25)	1 (13)	1 (8)	4 (11)
Investigations	0 (0)	0 (0)	0 (0)	1 (8)	1 (3)
Metabolism and nutrition disorders	1 (13)	0 (0)	0 (0)	0 (0)	1 (3)

^aDifferent dosing regiments consisted of 3 mg/kg, 7.5 mg/kg, and 15 mg/kg once daily for 5 days (multiple ascending dose study); different dosing conditions consisted of a single dose of 3 mg/kg under the fasted state and the fed state (food effect study). Data are presented as the number (%) of subjects with adverse events (AEs).