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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Olorofim

• Registration Number: NCT04207957
• Lead Sponsor: F2G Biotech GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-05
• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-23
• Primary Completion: 2020-09-15
• Study Completion: 2020-09-15
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-07
• Last Update Posted: 2021-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IV	Olorofim	2 h IV infusion (Groups A/B)
oral (fasted)	Olorofim	30 mg tablets given after an overnight fast (Groups A/B)
oral (fed)	Olorofim	30 mg tablets given after a high fat breakfast (Groups A/B)
oral (intact tablet)	Olorofim	30 mg tablets (Group C)
oral (NG tube)	Olorofim	30 mg tablets in water via NG tube (Group C)

Primary Outcome Measures

Name	Time	Method
Absolute bioavailability of olorofim (F)	35 days
maximum plasma concentration (Cmax) for olorofim	35 days
area under the concentration time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim	35 days

Secondary Outcome Measures

Name	Time	Method
Time to Cmax (TMax) for olorofim	35 days
area under the concentration time curve to infinity (AUC0-∞) for olorofim	35 days
terminal elimination half-life (t½) for olorofim	35 days
Number of subjects with treatment-related adverse events	35 days

Trial Locations

Locations (1)

Covance Clinical Research Unit; 🇬🇧 Leeds, West Yorkshire, United Kingdom