NCT04166669 is a Phase 1 clinical trial of APX001 in Fungal Infection, sponsored by Basilea Pharmaceutica.

Who is sponsoring NCT04166669?

NCT04166669 is sponsored by Basilea Pharmaceutica.

What drugs are being tested in NCT04166669?

Interventions in NCT04166669: APX001, Itraconazole, Rifampin.

What condition does NCT04166669 study?

NCT04166669 studies Fungal Infection.

Is NCT04166669 still recruiting?

NCT04166669 is currently completed. Last updated 17 May 2024.

Last reviewed 2024-05-17 · How we verify

NCT04166669

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 17 May 2024

What this trial tests

Phase 1 trial testing APX001 in Fungal Infection in 36 participants. Completed in 3 March 2020.

Timeline

12 November 2019

Primary endpoint
3 March 2020

3 March 2020

Quick facts

Lead sponsor	Basilea Pharmaceutica
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	12 November 2019
Primary completion	3 March 2020
Estimated completion	3 March 2020
Sites	2 locations across Netherlands

Drugs / interventions tested

APX001 — full drug profile →
Itraconazole — full drug profile →
Rifampin — full drug profile →

Conditions studied

Fungal Infection — all drugs for Fungal Infection →

Sponsor

Basilea Pharmaceutica — full company profile →

Who can join

Adults 18 to 60, any sex, with Fungal Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The Antifungal Pipeline: Fosmanogepix, Ibrexafungerp, Olorofim, Opelconazole, and Rezafungin.
Hoenigl M, Sprute R, Egger M, Arastehfar A, et al · · 2021 · cited 303× · PMID 34626339 · DOI 10.1007/s40265-021-01611-0
Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections.
Shaw KJ, Ibrahim AS. · · 2020 · cited 145× · PMID 33105672 · DOI 10.3390/jof6040239
Novel antifungals and treatment approaches to tackle resistance and improve outcomes of invasive fungal disease.
Hoenigl M, Arastehfar A, Arendrup MC, Brüggemann R, et al · · 2024 · cited 86× · PMID 38602408 · DOI 10.1128/cmr.00074-23
Drug Resistance and Novel Therapeutic Approaches in Invasive Candidiasis.
Murphy SE, Bicanic T. · · 2021 · cited 55× · PMID 34970504 · DOI 10.3389/fcimb.2021.759408
Clinical safety and efficacy of novel antifungal, fosmanogepix, for the treatment of candidaemia: results from a Phase 2 trial.
Pappas PG, Vazquez JA, Oren I, Rahav G, et al · · 2023 · cited 46× · PMID 37596890 · DOI 10.1093/jac/dkad256
Investigational Agents for the Treatment of Resistant Yeasts and Molds.
Seiler GT, Ostrosky-Zeichner L. · · 2021 · cited 23× · PMID 34075318 · DOI 10.1007/s12281-021-00419-5
Novel Promising Antifungal Target Proteins for Conquering Invasive Fungal Infections.
Zhen C, Lu H, Jiang Y. · · 2022 · cited 20× · PMID 35783432 · DOI 10.3389/fmicb.2022.911322
Fosmanogepix: The Novel Anti-Fungal Agent's Comprehensive Review of in Vitro, in Vivo, and Current Insights From Advancing Clinical Trials.
Almajid A, Bazroon A, Al-Awami HM, Albarbari H, et al · · 2024 · cited 14× · PMID 38807795 · DOI 10.7759/cureus.59210

Verify or expand the search:

Other trials of APX001

Trials testing the same drug.

NCT05491733 — A Bioequivalence Study of APX001 High-load and Low-load Tablets · Phase 1 · completed
NCT04148287 — An Open-label Study of APX001 for Treatment of Patients With Candidemia/Invasive Candidiasis Caused by Candida Auris · Phase 2 · completed
NCT03604705 — An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia · Phase 2 · completed

Other recruiting trials for Fungal Infection

Currently open trials in the same condition.

NCT07238114 — Liver Cirrhosis Patients With Invasive Pulmonary Aspergillosis: in Depth Understanding Clinical Host Risk Factors · active not recruiting
NCT06510699 — Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial · Phase 2 · recruiting
NCT05814432 — Efficacy and Safety of High-dose Liposomal Amphotericin B for Disseminated Histoplasmosis in AIDS · Phase 3 · recruiting
NCT03717623 — Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants · Phase 4 · recruiting
NCT03828773 — PTX3-targeted Antifungal Prophylaxis · NA · recruiting

Other Basilea Pharmaceutica trials

Trials by the same sponsor.

NCT06961708 — A Study of Fosmanogepix in Healthy Adult Chinese Subjects · Phase 1 · completed
NCT06808646 — A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin · Phase 1 · completed
NCT06733675 — Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination · Phase 1 · recruiting
NCT05421858 — A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invas · Phase 3 · recruiting
NCT06665555 — Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04166669 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Basilea Pharmaceutica
Last refreshed: 17 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04166669.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing