Healthy
Conditions
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
Interventions
DRUGOlorofim
150 mg
Sponsors
Covance
F2G Biotech GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
3 Treatment Periods for Cohorts A and B 2 Treatment Periods for Cohort C
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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/m2. * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum plasma concentration (Cmax) for olorofim | 35 days |
| area under the concentration time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim | 35 days |
| Absolute bioavailability of olorofim (F) | 35 days |
Secondary
| Measure | Time frame |
|---|---|
| Time to Cmax (TMax) for olorofim | 35 days |
| Number of subjects with treatment-related adverse events | 35 days |
| area under the concentration time curve to infinity (AUC0-∞) for olorofim | 35 days |
| terminal elimination half-life (t½) for olorofim | 35 days |
Countries
United Kingdom
Outcome results
None listed