Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-31 @ 9:40 AM
Study NCT ID:
NCT02755857
Status:
COMPLETED
Last Update Posted:
2018-10-26
First Post:
2016-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study of Lozanoc™ 65 mg Itraconazole Capsules in Patients Requiring Prophylaxis
Sponsor:
Mayne Pharma International Pty Ltd
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: