A Phase I, Open-label, Randomised Biopharmaceutics Study in Healthy Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability of Single Doses of IV and Oral Formulations of Olorofim
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- F2G Biotech GmbH
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Absolute bioavailability of olorofim (F)
Study Overview
Brief Summary
This is a Phase I, single-centre, randomised, open-label, crossover study in 24 healthy subjects. Twelve subjects will each receive olorofim as a single IV infusion, single oral dose (fasted) and single oral dose (fed) and 12 subjects will each receive olorofim orally as intact tablets and via NG tube
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •males or females of any ethnic origin between 18 and 55 years of age
- •subjects weighing between 50 and 100 kg, with a body mass index (BMI) between 18 and 30 kg/m
- •subjects in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations
Exclusion Criteria
- •Male subjects (or their partners) who are not willing to use appropriate contraception during the study and for 3 months after end of dosing.
- •Female subjects who are pregnant or lactating.
- •Subjects who have received any prescribed systemic or topical medication within 14 days of first dose administration
- •Subjects who have used any non-prescribed systemic or topical medication within 7 days of first dose administration
- •Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of first dose administration
- •Subjects with or history of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatry, respiratory, metabolic, endocrine, ocular haematological or other major disorders as determined by the investigator
Arms & Interventions
oral (fed)
30 mg tablets given after a high fat breakfast (Groups A/B)
Intervention: Olorofim (Drug)
oral (fasted)
30 mg tablets given after an overnight fast (Groups A/B)
Intervention: Olorofim (Drug)
IV
2 h IV infusion (Groups A/B)
Intervention: Olorofim (Drug)
oral (intact tablet)
30 mg tablets (Group C)
Intervention: Olorofim (Drug)
oral (NG tube)
30 mg tablets in water via NG tube (Group C)
Intervention: Olorofim (Drug)
Outcomes
Primary Outcomes
Absolute bioavailability of olorofim (F)
Time Frame: 35 days
maximum plasma concentration (Cmax) for olorofim
Time Frame: 35 days
area under the concentration time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim
Time Frame: 35 days
Secondary Outcomes
- Time to Cmax (TMax) for olorofim(35 days)
- area under the concentration time curve to infinity (AUC0-∞) for olorofim(35 days)
- terminal elimination half-life (t½) for olorofim(35 days)
- Number of subjects with treatment-related adverse events(35 days)