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

NCT04207957 | Completed Phase 1

• 1 other identifier: F901318-01-14
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (5)

IV

OTHER

2 h IV infusion (Groups A/B)

Drug: Olorofim

oral (fasted)

OTHER

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

Drug: Olorofim

oral (fed)

OTHER

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

Drug: Olorofim

oral (intact tablet)

OTHER

30 mg tablets (Group C)

Drug: Olorofim

oral (NG tube)

OTHER

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

Drug: Olorofim

Interventions

Olorofim DRUG

150 mg

Also known as: F901318

IV; oral (NG tube); oral (fasted); oral (fed); oral (intact tablet)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• F2G Biotech GmbH: lead
• Covance: collaborator

Study Sites (1)

Covance Clinical Research Unit

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

olorofim

Study Officials

• Jim Bush, MBChB

  Covance CRU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3 Treatment Periods for Cohorts A and B 2 Treatment Periods for Cohort C

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: December 5, 2019
• Primary Completion: September 15, 2020
• Study Completion: September 15, 2020
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)