drugset / Trial / NCT04039880

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

NCT04039880

Phase 1 Completed 12 enrolled F2G Ltd PRA Health Sciences · collab
Non-randomizedSequentialOpen-labelOther

Summary

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).

Timeline

Start
2019-07-30
Primary completion
2019-09-30
Completion
2019-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Olorofim Small molecule 3.7 mbq Oral
Subject Olorofim Small molecule 120 mg Oral