Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02621905
Recruitment Status : Completed
First Posted : December 4, 2015
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Mayne Pharma International Pty Ltd

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.

Condition or disease Intervention/treatment Phase
Neutropenia Drug: Sporanox Drug: Lozanoc Phase 4

Detailed Description:

After confirmation of eligibility, participants will be randomly assigned 1:1 to commence therapy with either 100mg mane and 100mg nocte for 21 days or Sporanox 200mg mane and 200mg nocte with food for 21 days. If a subject enters the study already receiving itraconazole prophylaxis at a dose of itraconazole higher than 100 mg twice a day, the subject will then be dosed on study at the pre-study dosage; that is, the subject will take the same number of capsules per day on study as the subject was taking prior to enrolment in the study.

The following information will be collected at baseline; whether the participant is taking itraconazole prophylaxis and at what dose; whether the participant is taking gastric suppression therapy. Patients who are not taking food or who are taking gastric acid suppression therapy (antacids, an H2 antagonist or a proton pump inhibitor) can take Sporanox with cola or orange juice to maximise absorption as recommended in the Sporanox product label (not required for Lozanoc formulation).

At Day 22, participants assigned to

  • Lozanoc and who have completed 21 days of Lozanoc prophylaxis will cross over to the same number of Sporanox capsules with food for a further 21 days
  • Sporanox and who have completed 21 days of Sporanox prophylaxis will cross over to the same number of Lozanoc capsules for a further 21 days.

The dose of either drug may be dose-reduced or ceased for toxicity at the discretion of the investigator.

During the course of the treatment periods participants will undergo the following assessments:

  • Concurrent medication(s)
  • Clinical adverse events
  • Measurement of vital signs (weight, blood pressure, temperature)
  • Targeted physical examination
  • Documentation of any evidence of systemic fungal infection
  • Medication and meal diaries
  • 12-lead electrocardiogram (ECG)
  • Laboratory safety assessments: Renal function and electrolytes (urea, creatinine, estimated glomerular filtration rate [eGFR], sodium, potassium, chloride, bicarbonate), Liver function tests (bilirubin, albumin, total protein, alanine aminotransferase [ALT], aspartate aminotransferase [AST])
  • Pharmacokinetic testing: Trough (pre-morning dose; 0 hr) sample will be collected at Baseline (Day 1), and at Days 8, 15, 22, 29, 36 and 43. Post-dose samples will also be collected 2, 3.5 and 6 hours after the morning dose on Day 22 and Day 43

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Steady-State Comparative Bioavailability Study in Patients Requiring Anti-Fungal Prophylaxis Comparing Twice a Day Dosing of Lozanoc® (Mayne) Regardless of Food With Sporanox® (Janssen) Under Fed Conditions
Actual Study Start Date : November 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Sporanox
100 mg
Drug: Sporanox
At least 2 capsules twice a day for 3 weeks
Other Name: itraconazole

Experimental: Lozanoc
50 mg
Drug: Lozanoc
At least 2 capsules twice a day for 3 weeks
Other Name: itraconazole




Primary Outcome Measures :
  1. Relative steady-state bioavailability [ Time Frame: 3 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02621905


Locations
Layout table for location information
Australia, New South Wales
St Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Sponsors and Collaborators
Mayne Pharma International Pty Ltd
Investigators
Layout table for investigator information
Principal Investigator: Deborah Marriott St Vincent's Hospital, Sydney

Layout table for additonal information
Responsible Party: Mayne Pharma International Pty Ltd
ClinicalTrials.gov Identifier: NCT02621905     History of Changes
Other Study ID Numbers: MPG010
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data will not be made available

Keywords provided by Mayne Pharma International Pty Ltd:
Prophylaxis
Steady-State
Bioavailability

Additional relevant MeSH terms:
Layout table for MeSH terms
Itraconazole
Hydroxyitraconazole
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors