A Study to Assess the Mass Balance Recovery and Metabolite Profile & Identification of [14C]-APX001 in Healthy Males
Status:
Completed
Trial end date:
2018-09-26
Target enrollment:
Participant gender:
Summary
This is a single-center, open-label, non-randomized, single dose study in healthy male
subjects. It was planned to enroll 2 cohorts of 5 subjects (10 subjects in total), with the
target of achieving data in 4 evaluable subjects per cohort. Five subjects were to receive a
single oral dose of APX001 and not more than (NMT) 3.1 megabecquerel (MBq) (84.0 microcurie
[μCi]) 14C in the fed state. Five subjects were to receive a single IV administration
containing APX001 and NMT 3.4 MBq (93.0 μCi) 14C in the fed state.