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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04207957
• Other study ID #: F901318-01-14
• Status: Completed
• Phase: Phase 1
• Start date: December 5, 2019
• Est. completion date: September 15, 2020

Study information

• Verified date: January 2021
• Source: F2G Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Olorofim
150 mg

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit	Leeds	West Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
F2G Ltd.	Covance

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum plasma concentration (Cmax) for olorofim		35 days
Primary	area under the concentration time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim		35 days
Primary	Absolute bioavailability of olorofim (F)		35 days
Secondary	Time to Cmax (TMax) for olorofim		35 days
Secondary	area under the concentration time curve to infinity (AUC0-8) for olorofim		35 days
Secondary	terminal elimination half-life (t½) for olorofim		35 days
Secondary	Number of subjects with treatment-related adverse events		35 days