Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 54 of 205 for:    SPORANOX I.V. OR ITRACONAZOLE OR ONMEL OR SPORANOX-PULSE OR Sporanos OR R 51,211 OR SPORANOX

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

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: NCT02755857
Recruitment Status : Completed
First Posted : April 29, 2016
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Mayne Pharma International Pty Ltd

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.

Condition or disease Intervention/treatment Phase
Neutropenia Drug: Lozanoc Phase 2

Detailed Description:

After confirmation of eligibility, participants will take their last dose of current itraconazole therapy (Lozanoc 50mg capsules or Sporanox 100mg capsules) on the morning of Day 1, and commence therapy with Lozanoc 65 mg capsules for 21 days from the evening of Day 1.

The number of Lozanoc 65mg capsules to be taken by the participant will be 2 capsules (130mg) morning and evening OR the same number of Lozanoc 50mg capsules that the participant received in study MPG010, if applicable. That is, if the participant received 3 x 50mg Lozanoc capsules morning and evening on study MPG010 he/she will receive 3 x 65 mg Lozanoc 65 mg capsules, morning and evening in study MPG011

The dose of study drug (Lozanoc 65mg) may be dose-reduced or ceased for toxicity at the discretion of the investigator.

Participants will undergo the following assessments during the course of the study:

  • 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, chlorine, bicarbonate)
    • Liver function tests (bilirubin, albumin, total protein, alanine aminotransferase [ALT], aspartate aminotransferase [AST])
  • Pharmacokinetic testing

    • pre-morning dose (0 h sample) at Baseline (Day 1), and at Days 8, 15, and 22
    • at 2, 3.5 and 6 hours post the morning dose at Baseline (Day 1) and Day 22

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Single-arm, Multiple-Dose, Steady-State, Bioavailability Study With Twice Daily Dosing of Lozanoc™ (65 mg Itraconazole Capsules, Mayne) Taken Regardless of Food
Actual Study Start Date : July 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lozanoc
65 mg, capsules, at least 2 capsules twice a day
Drug: Lozanoc
65 mg
Other Name: itraconazole




Primary Outcome Measures :
  1. Steady-state plasma itraconazole concentrations [ 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 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

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): NCT02755857


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, MBBS BSc(MED) FRACP FRCPA St. Vincent's Hospital-Manhattan

Layout table for additonal information
Responsible Party: Mayne Pharma International Pty Ltd
ClinicalTrials.gov Identifier: NCT02755857     History of Changes
Other Study ID Numbers: MPG011
First Posted: April 29, 2016    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
Bioavailability
Pharmacokinetics

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