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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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.

Detailed Summary:

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)
  • Sponsor: Mayne Pharma International Pty Ltd
    

    Current Primary Outcome: Steady-state plasma itraconazole concentrations [ Time Frame: 3 weeks ]
    
    

    Original Primary Outcome: Same as current
    
    

    Current Secondary Outcome:
    
    

    Original Secondary Outcome:
    
    Information By: Mayne Pharma International Pty Ltd
    

    Dates:
    Date Received: April 28, 2016
    Date Started: July 2016
    Date Completion: January 2017
    Last Updated: July 19, 2016
    Last Verified: July 2016