3.1 Subject Disposition
Demographic characteristics were consistent across the three studies
(Table 2). In the SAD study, one subject in the 1 mg LSF cohort was
withdrawn from the study due to an AE. He received an incomplete dose of
0.1 mg emodepside in error. He was included in the safety assessment,
but not the PK assessments. Only 5 of the planned 6 subjects were
included in the 5 mg IR tablet cohort. In the MAD study, all subjects
received the IP as intended. In the RBA study, only 55 of the planned 60
subjects were included in Part 1, and only 22 of the planned 24 subjects
in Part 2. In addition, in Part 1, two subjects withdrew from the study,
however their data were included in the PK and safety assessments, up to
48 hours post-dose for one and up to 120 hours post-dose for the other.
3.2 PK Parameters