NCT02755857

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

A Single-arm, Multiple-Dose, Steady-State, Bioavailability Study With Twice Daily Dosing of Lozanoc™ (65 mg Itraconazole Capsules, Mayne) Taken Regardless of Food

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Mayne Pharma International Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Neutropenia

Interventions

Type	Name	Description
DRUG	Lozanoc	65 mg

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-12-01
• Completion: 2017-01-01
• First posted: 2016-04-29
• Last updated: 2018-10-26

Locations

1 site across 1 country: Australia