Overview
Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim
Status:
Completed
Completed
Trial end date:
2020-02-11
2020-02-11
Target enrollment:
0
0
Participant gender:
All
All
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 .Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
F2G Biotech GmbH
F2G Ltd.Collaborator:
Hammersmith Medicines ResearchTreatments:
Hydroxyitraconazole
Itraconazole
Olorofim
Rifampin
Criteria
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