NCT04207957

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: F2G Biotech GmbH · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Olorofim	150 mg

Timeline

• Start date: 2019-12-05
• Primary completion: 2020-09-15
• Completion: 2020-09-15
• First posted: 2019-12-23
• Last updated: 2021-01-08

Locations

1 site across 1 country: United Kingdom