Healthy
Conditions
Brief summary
This is a Phase 1, single-centre, fixed-sequence, open label, drug-drug interaction study in 2 groups of healthy subjects. Group A: to evaluate the effects of itraconazole, a strong inhibitor of cytochrome P450 3A (CYP3A), upon the pharmacokinetics of olorofim . Group B: t o evaluate the effects rifampicin, a strong inducer of CYP3A, upon the pharmacokinetics of olorofim .
Interventions
200 mg once daily on Days 6 to 15
DRUGRifampicin Oral Capsule
600 mg once daily on Days 6 to 15
DRUGOlorofim
Single oral dose on Days 1 and 11
Sponsors
Hammersmith Medicines Research
F2G Biotech GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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 32 kg/m2. * subjects in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations
Exclusion criteria
* Female subjects of child-bearing potential. * 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. | 16 days |
| Area under the concentration-time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim. | 16 days |
Secondary
| Measure | Time frame |
|---|---|
| Time to Cmax (Tmax) of olorofim | 16 days |
| area under the concentration-time curve to infinity (AUC0-∞) for olorofim | 16 days |
| terminal elimination half-life (t½) for olorofim | 16 days |
| Number of subjects with treatment-related adverse events | 23 days |
Countries
United Kingdom
Outcome results
None listed