NCT04166669

A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001

A Phase 1, Open-Label, Fixed-Sequence, Drug-Drug Interaction Study of APX001 to Evaluate the Effects of CYP3A4 Inhibition and Pan-CYP Induction in Two Parallel Groups of Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, open-label study to evaluate the drug-drug interaction potential of a strong CYP3A4 inhibitor (itraconazole) and a pan-CYP inducer (rifampin) on APX001 in two parallel groups of healthy subjects.

Conditions

• Fungal Infection

Interventions

Type	Name	Description
DRUG	APX001	Cohort 1 Day 1: APX001 500 mg IV BID over a 3-hour infusion; Day 18: APX001 500 mg IV BID over a 3-hour infusion. Cohort 2 Day 1: APX001 1000 mg IV BID over a 3-hour infusion; Day 24: APX001 1000 mg IV BID over a 3-hour infusion.
DRUG	Itraconazole	Cohort 1 Days 15-30: itraconazole 200 mg oral solution QD.
DRUG	Rifampin	Cohort 2 Days 15-33: rifampin 600 mg oral QD.

Timeline

• Start date: 2019-11-12
• Primary completion: 2020-03-03
• Completion: 2020-03-03
• First posted: 2019-11-18
• Last updated: 2024-05-17

Locations

2 sites across 1 country: Netherlands

Regulatory

• FDA-regulated drug study