Bioavailability Study of Lozanoc™ 65 mg Itraconazole Capsules in Patients Requiring Prophylaxis

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This open-labelled, single arm study is a follow-on from Study MPG010 to compare the relative bioavailability of Lozanoc 65 mg Capsules against Lozanoc 50 mg Capsules and Sporanox 100 mg Capsules in patients requiring itraconazole anti-fungal prophylaxis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayne Pharma International Pty Ltd
• Treatments: Hydroxyitraconazole; Itraconazole

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