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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

Tracking Information
First Submitted Date  ICMJE December 2, 2015
First Posted Date  ICMJE December 4, 2015
Last Update Posted Date October 26, 2018
Actual Study Start Date  ICMJE November 2015
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2015)
Relative steady-state bioavailability [ Time Frame: 3 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Steady-State Comparative Bioavailability Study in Prophylaxis Patients of Lozanoc® 50 mg With Sporanox® 100 mg
Official Title  ICMJE 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
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.
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Neutropenia
Intervention  ICMJE
  • Drug: Sporanox
    At least 2 capsules twice a day for 3 weeks
    Other Name: itraconazole
  • Drug: Lozanoc
    At least 2 capsules twice a day for 3 weeks
    Other Name: itraconazole
Study Arms  ICMJE
  • Active Comparator: Sporanox
    100 mg
    Intervention: Drug: Sporanox
  • Experimental: Lozanoc
    50 mg
    Intervention: Drug: Lozanoc
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2015)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02621905
Other Study ID Numbers  ICMJE MPG010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual patient data will not be made available
Current Responsible Party Mayne Pharma International Pty Ltd
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Mayne Pharma International Pty Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deborah Marriott St Vincent's Hospital, Sydney
PRS Account Mayne Pharma International Pty Ltd
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP