NCT04804059

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

An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-APX001 in Healthy Male Subjects After Oral and Intravenous Dosing

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fungal Infection

Interventions

Type	Name	Description
DRUG	[14C]-APX001 Oral Solution	Total dose containing NMT 3.1 MBq (84.0 µCi) 14C
DRUG	[14C]-APX001 Solution for Infusion	Total dose containing NMT 3.4 MBq (93.0 µCi) 14C

Timeline

• Start date: 2018-08-17
• Primary completion: 2018-09-26
• Completion: 2018-09-26
• First posted: 2021-03-18
• Last updated: 2024-05-17

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study