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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02621905




Registration number
NCT02621905
Ethics application status
Date submitted
2/12/2015
Date registered
4/12/2015
Date last updated
26/10/2018

Titles & IDs
Public title
Steady-State Comparative Bioavailability Study in Prophylaxis Patients of Lozanoc® 50 mg With Sporanox® 100 mg
Scientific title
Steady-State Comparative Bioavailability Study in Patients Requiring Anti-Fungal Prophylaxis Comparing Twice a Day Dosing of Lozanoc® (Mayne) Regardless of Food With Sporanox® (Janssen) Under Fed Conditions
Secondary ID [1] 0 0
MPG010
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 - Sporanox
Treatment: Drugs - Lozanoc

Active comparator: Sporanox - 100 mg

Experimental: Lozanoc - 50 mg


Treatment: Drugs: Sporanox
At least 2 capsules twice a day for 3 weeks

Treatment: Drugs: Lozanoc
At least 2 capsules twice a day for 3 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Relative steady-state bioavailability
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 primary prophylaxis against systemic fungal infections with itraconazole in patients who have had or about to have: a heart, lung or bone marrow transplant, combination chemotherapy for cancer; aspergilloma, chronic pulmonary aspergillus bronchitis, or allergic bronchopulmonary aspergillosis
* Patients may be receiving itraconazole prophylaxis prior to entry into the study
* 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
* Congestive cardiac failure or other causes of ventricular dysfunction that may outweigh the benefit of itraconazole
* Hypersensitivity to either study drug or to any of their excipients
* Coadministration of the following drugs:

* CYP3A4 metabolised substrates that can prolong the QT-interval e.g., sertindole, terfenadine
* CYP3A4 metabolised HMG-CoA reductase inhibitors e.g. simvastatin, lovastatin
* Potent CYP3A4 inhibitors e.g. dronedarone
* Triazolam, alprazolam and oral midazolam
* Ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine) and ergotamine

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
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
Crossover
Other design features
Phase
Phase 4
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
1/11/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
40
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
The pharmacokinetics of Sporanox and Lozanoc has not been compared in patients requiring anti-fungal prophylaxis or therapy. The present study is designed to compare the pharmacokinetics of Sporanox and Lozanoc in patients requiring primary prophylaxis. The 3-week exposure to each formulation is designed to allow for all participants to reach steady-state for each drug, as the time to steady-state can vary.
Trial website
https://clinicaltrials.gov/study/NCT02621905
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Deborah Marriott
Address 0 0
St Vincent's Hospital, Sydney
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/study/NCT02621905