Steady-State Comparative Bioavailability Study in Prophylaxis Patients of Lozanoc® 50 mg With Sporanox® 100 mg

NCT02621905 | Completed Phase 4

• 1 other identifier: MPG010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The pharmacokinetics of Sporanox and Lozanoc has not been compared in patients requiring anti-fungal prophylaxis or therapy. The present study is designed to compare the pharmacokinetics of Sporanox and Lozanoc in patients requiring primary prophylaxis. The 3-week exposure to each formulation is designed to allow for all participants to reach steady-state for each drug, as the time to steady-state can vary.

Conditions

Neutropenia

Keywords

Prophylaxis; Steady-State; Bioavailability

Outcome Measures

Primary Outcomes (1)

• Relative steady-state bioavailability

  3 weeks

Study Arms (2)

Sporanox

ACTIVE COMPARATOR

100 mg

Drug: Sporanox

Lozanoc

EXPERIMENTAL

50 mg

Drug: Lozanoc

Interventions

Sporanox DRUG

At least 2 capsules twice a day for 3 weeks

Also known as: itraconazole

Sporanox

Lozanoc DRUG

At least 2 capsules twice a day for 3 weeks

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 primary prophylaxis against systemic fungal infections with itraconazole in patients who have had or about to have: a heart, lung or bone marrow transplant, combination chemotherapy for cancer; aspergilloma, chronic pulmonary aspergillus bronchitis, or allergic bronchopulmonary aspergillosis
• Patients may be receiving itraconazole prophylaxis prior to entry into the study
• Body mass index between 15.0 and 35.0 kg/m2

You may not qualify if:

• Pregnant, planning pregnancy or breastfeeding
• Congestive cardiac failure or other causes of ventricular dysfunction that may outweigh the benefit of itraconazole
• Hypersensitivity to either study drug or to any of their excipients
• Coadministration of the following drugs:
• CYP3A4 metabolised substrates that can prolong the QT-interval e.g., sertindole, terfenadine
• CYP3A4 metabolised HMG-CoA reductase inhibitors e.g. simvastatin, lovastatin
• Potent CYP3A4 inhibitors e.g. 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

  St Vincent's Hospital, Sydney

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 4, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)