NCT02957929

Safety, Pharmacokinetics, Bioavailability, Food Effect, Drug-Drug Interaction Study of APX001 Administered Orally

A Phase 1, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of APX001, to Investigate the Effect of Food on APX001 and to Investigate the Drug-Drug Interaction Potential of APX001

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase l double-blind, placebo-controlled, randomized study to investigate the safety, tolerability, pharmacokinetics, bioavailability and food effect of single doses of APX001 administered intravenously and orally, followed by an evaluation of the safety, tolerability, pharmacokinetics and drug-drug interaction potential of multiple doses of APX001 administered orally.

Conditions

• Fungal Infection

Interventions

Type	Name	Description
DRUG	APX001 single IV dose
DRUG	APX001 single oral dose 1
DRUG	APX001 single oral dose 2
DRUG	APX001 single oral dose 3
DRUG	APX001 single oral dose fasted
DRUG	APX001 single oral dose fed
DRUG	APX001 multiple oral doses 1
DRUG	APX001 multiple oral doses 2
DRUG	APX001 multiple oral doses 3
DRUG	Cytochrome P450 substrates
DRUG	Matching placebo control

Timeline

• Start date: 2016-10-31
• Primary completion: 2017-04-20
• Completion: 2017-04-20
• First posted: 2016-11-08
• Last updated: 2025-09-10

Locations

2 sites across 1 country: Netherlands