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

A Phase I, Open-label, Randomised Biopharmaceutics Study in Healthy Subjects to Evaluate the Pharmacokinetics, Safety and Tolerability of Single Doses of IV and Oral Formulations of Olorofim

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Olorofim

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS2 9LH
      • Covance Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: IV; 2 h IV infusion (Groups A/B)	Drug: Olorofim; 150 mg; Other Names: F901318
Other: oral (fasted); 30 mg tablets given after an overnight fast (Groups A/B)	Drug: Olorofim; 150 mg; Other Names: F901318
Other: oral (fed); 30 mg tablets given after a high fat breakfast (Groups A/B)	Drug: Olorofim; 150 mg; Other Names: F901318
Other: oral (intact tablet); 30 mg tablets (Group C)	Drug: Olorofim; 150 mg; Other Names: F901318
Other: oral (NG tube); 30 mg tablets in water via NG tube (Group C)	Drug: Olorofim; 150 mg; Other Names: F901318

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Absolute bioavailability of olorofim (F)	35 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: F2G Biotech GmbH
• Collaborators: Covance
• Investigators: Principal Investigator: Jim Bush, MBChB, Covance CRU

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2019
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): September 15, 2020

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 7, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antifungal Agents; Olorofim
• Other Study ID Numbers: F901318-01-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No