A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of Olorofim

F2G Biotech

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Olorofim

Study type: Interventional

Funder types: Industry

Identifiers

NCT04207957

F901318-01-14

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 5 patient groups

IV

Other group

Description:

2 h IV infusion (Groups A/B)

Treatment:

Drug: Olorofim

oral (fasted)

Other group

Description:

30 mg tablets given after an overnight fast (Groups A/B)

Treatment:

Drug: Olorofim

oral (fed)

Other group

Description:

30 mg tablets given after a high fat breakfast (Groups A/B)

Treatment:

Drug: Olorofim

oral (intact tablet)

Other group

Description:

30 mg tablets (Group C)

Treatment:

Drug: Olorofim

oral (NG tube)

Other group

Description:

30 mg tablets in water via NG tube (Group C)

Treatment:

Drug: Olorofim