NCT04171739

Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim

A Phase I, Open Label Study in Healthy Subjects to Evaluate the Effect of Itraconazole and Rifampicin Upon the Pharmacokinetics of a Single Oral Dose 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 1, single-centre, fixed-sequence, open label, drug-drug interaction study in 2 groups of healthy subjects. Group A: to evaluate the effects of itraconazole, a strong inhibitor of cytochrome P450 3A (CYP3A), upon the pharmacokinetics of olorofim . Group B: t o evaluate the effects rifampicin, a strong inducer of CYP3A, upon the pharmacokinetics of olorofim .

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Itraconazole oral solution	200 mg once daily on Days 6 to 15
DRUG	Rifampicin Oral Capsule	600 mg once daily on Days 6 to 15
DRUG	Olorofim	Single oral dose on Days 1 and 11

Timeline

• Start date: 2019-11-18
• Primary completion: 2020-02-11
• Completion: 2020-02-11
• First posted: 2019-11-21
• Last updated: 2020-07-24

Locations

1 site across 1 country: United Kingdom