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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02755857




Registration number
NCT02755857
Ethics application status
Date submitted
28/04/2016
Date registered
29/04/2016
Date last updated
26/10/2018

Titles & IDs
Public title
Bioavailability Study of Lozanoc™ 65 mg Itraconazole Capsules in Patients Requiring Prophylaxis
Scientific 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
Secondary ID [1] 0 0
MPG011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neutropenia 0 0
Condition category
Condition code
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lozanoc

Experimental: Lozanoc - 65 mg, capsules, at least 2 capsules twice a day


Treatment: Drugs: Lozanoc
65 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Steady-state plasma itraconazole concentrations
Timepoint [1] 0 0
3 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2017
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mayne Pharma International Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02755857
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Deborah Marriott, MBBS BSc(MED) FRACP FRCPA
Address 0 0
St Vincent's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02755857