Absorption, Metabolism and Excretion of 14C-olorofim in Man (hAME)

NCT04039880 PHASE1 COMPLETED

Single-centre, open-label, non-randomised, single dose study in 2 cohorts of healthy subjects. It is planned to enrol 6 healthy male subjects in Cohort A (standard mass balance and metabolite profiling cohort) and up to 6 subjects in Cohort B (biliary evaluation cohort); each subject will receive a single oral administration of 120 mg \[14C\]-olorofim oral solution containing approximately 3.7 MBq (100 µCi).

Details

Lead sponsor	F2G Biotech GmbH
Phase	PHASE1
Status	COMPLETED
Enrolment	12
Start date	Tue Jul 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Sep 30 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Invasive Fungal Infections

Interventions

• Olorofim

Countries

Netherlands