Absorption, Metabolism and Excretion of 14C-olorofim in Man
- Sponsor
- F2G Ltd
- Study ID
- NCT04039880
- Phase
- PHASE1
- Status
- Completed
Conditions
- Invasive Fungal Infections
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- Olorofim — DRUGsingle oral dose (120 mg, 3.7 MBq)
Study Details
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).
Key Dates
- Start date
- Jul 30, 2019
- Status verified
- Aug 2019
- Primary completion
- Sep 30, 2019
- Completion
- Sep 30, 2019
Study Design
- Enrollment
- 12 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- OTHER
Arms
- Experimental: Cohort A (mass balance)evaluation of mass balance and metabolite profiling
- Experimental: Cohort B (biliary evaluation)evaluation of biliary elimination
Primary Outcome Measure
Mass balance [ Time Frame: 28 days ]