Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim

• Status: Completed
• Trial end date: 2020-02-11
• Target enrollment: 0
• Participant gender: 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 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: F2G Biotech GmbH; F2G Ltd.
• Collaborator: Hammersmith Medicines Research
• Treatments: 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