Overview

Bioavailability Study of Lozanocâ„¢ 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