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 .
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
24
200 mg once daily on Days 6 to 15
600 mg once daily on Days 6 to 15
Single oral dose on Days 1 and 11
Hammersmith Medicines Research
London, United Kingdom
maximum plasma concentration (Cmax) for olorofim.
Time frame: 16 days
Area under the concentration-time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim.
Time frame: 16 days
Time to Cmax (Tmax) of olorofim
Time frame: 16 days
area under the concentration-time curve to infinity (AUC0-∞) for olorofim
Time frame: 16 days
terminal elimination half-life (t½) for olorofim
Time frame: 16 days
Number of subjects with treatment-related adverse events
Time frame: 23 days
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