Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT02755857
Eligibility Criteria:
Inclusion Criteria:
* Provision of written, informed consent
* Age of at least 18 years
* No clinical evidence of active systemic fungal infection
* Physician-recommended continuation of oral itraconazole as primary prophylaxis in patients at risk of systemic fungal infections or otherwise requiring a long-term itraconazole maintenance regimen, including patients:
* who have had or are about to have a heart, lung or bone marrow transplant
* on combination chemotherapy for cancer
* with an aspergilloma, chronic pulmonary aspergillus bronchitis, or allergic bronchopulmonary aspergillosis
* At least 21 days of prior dosing with oral itraconazole, either Lozanoc 50mg capsules twice daily or Sporanox 100mg capsules twice daily.
* Body mass index between 15.0 and 35.0 kg/m2
Exclusion Criteria:
* Pregnant, planning pregnancy or breastfeeding
* Plasma itraconazole concentration greater than 1500ng/mL (in patients on Lozanoc 50mg capsules)
* Congestive cardiac failure or other causes of ventricular dysfunction that may outweigh the benefit of itraconazole
* Hypersensitivity to Lozanoc or to any of its excipients
* Coadministration of the following drugs:
* CYP3A4 metabolised substrates that can prolong the QT-interval: sertindole, terfenadine
* CYP3A4 metabolised 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors: simvastatin, lovastatin
* Potent CYP3A4 inhibitor: dronedarone
* Triazolam, alprazolam and oral midazolam
* Ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine) and ergotamine
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02755857
Study Brief:
Protocol Section:
NCT02755857