A Study to Assess the Mass Balance Recovery and Metabolite Profile & Identification of [14C]-APX001 in Healthy Males

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.

Timeline

Start

2018-08-17

Primary completion

2018-09-26

Completion

2018-09-26

Publications

• Hodges MR, Ople E, Evans P, Pantophlet AJ(, Richardson J, Williams D, Tripathy S, Tawadrous M, Jakate A. A phase 1 open label study to assess the human mass balance and metabolite profile of 14C-fosmanogepix, a novel Gwt-1 inhibitor in healthy male participants. Antimicrob Agents Chemother. 2024 Aug 7;68(8):e0027324. doi: 10.1128/aac.00273-24. Epub 2024 Jul 16.

Drugs

Indications