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

NCT02755857 | Completed Phase 2

• 1 other identifier: MPG011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neutropenia

Keywords

Prophylaxis; Bioavailability; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Steady-state plasma itraconazole concentrations

  3 weeks

Study Arms (1)

Lozanoc

EXPERIMENTAL

65 mg, capsules, at least 2 capsules twice a day

Drug: Lozanoc

Interventions

Lozanoc DRUG

65 mg

Also known as: itraconazole

Lozanoc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayne Pharma International Pty Ltd: lead

Study Sites (1)

St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

MeSH Terms

Conditions

Neutropenia

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Deborah Marriott, MBBS BSc(MED) FRACP FRCPA

  St Vincent's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: April 29, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)