drugset / Trial / NCT04039880
Absorption, Metabolism and Excretion of 14C-olorofim in Man
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olorofim | Small molecule | 3.7 mbq | Oral |
| Subject | Olorofim | Small molecule | 120 mg | Oral |