NeutropeniaPhase 4NCT02621905
Steady-State Comparative Bioavailability Study in Prophylaxis Patients of Lozanoc® 50 mg With Sporanox® 100 mg
A Phase 4 study testing Sporanox and Lozanoc in people with Neutropenia, run by Mayne Pharma International Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neutropenia
- What is being tested?
- Sporanox and Lozanoc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2015to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Potent CYP3A4 inhibitors e.g. dronedarone
- Triazolam, alprazolam and oral midazolam
- Ergot alkaloids such as dihydroergotamine, ergometrine (ergonovine) and ergotamine
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
After confirmation of eligibility, participants will be randomly assigned 1:1 to commence therapy with either 100mg mane and 100mg nocte for 21 days or Sporanox 200mg mane and 200mg nocte with food for 21 days. If a subject enters the study already receiving itraconazole prophylaxis at a dose of itraconazole higher than 100 mg twice a day, the subject will then be dosed on study at the pre-study dosage; that is, the subject will take the same number of capsules per day on study as the subject was taking prior to enrolment in the study.
The following information will be collected at baseline; whether the participant is taking itraconazole prophylaxis and at what dose; whether the participant is taking gastric suppression therapy. Patients who are not taking food or who are taking gastric acid suppression therapy (antacids, an H2 antagonist or a proton pump inhibitor) can take Sporanox with cola or orange juice to maximise absorption as recommended in the Sporanox product label (not required for Lozanoc formulation).
At Day 22, participants assigned to
- Lozanoc and who have completed 21 days of Lozanoc prophylaxis will cross over to the same number of Sporanox capsules with food for a further 21 days
- Sporanox and who have completed 21 days of Sporanox prophylaxis will cross over to the same number of Lozanoc capsules for a further 21 days.
The dose of either drug may be dose-reduced or ceased for toxicity at the discretion of the investigator.
During the course of the treatment periods participants will undergo the following assessments:
- 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, chloride, bicarbonate), Liver function tests (bilirubin, albumin, total protein, alanine aminotransferase [ALT], aspartate aminotransferase [AST])
- Pharmacokinetic testing: Trough (pre-morning dose; 0 hr) sample will be collected at Baseline (Day 1), and at Days 8, 15, 22, 29, 36 and 43. Post-dose samples will also be collected 2, 3.5 and 6 hours after the morning dose on Day 22 and Day 43
- Conditions
- Neutropenia
- Being tested
- Sporanox, Lozanoc
- Keywords
- Prophylaxis, Steady-State, Bioavailability
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SporanoxDrug
Also called itraconazole
At least 2 capsules twice a day for 3 weeks
LozanocDrug
Also called itraconazole
At least 2 capsules twice a day for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sporanox | Active comparator | 100 mg Receives: Drug: Sporanox |
| Lozanoc | Experimental | 50 mg Receives: Drug: Lozanoc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative steady-state bioavailability
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayne Pharma International Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deborah Marriott, Principal investigator, St Vincent's Hospital, Sydney
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621905
- Sponsor's protocol ID
- MPG010
- Status last verified
- Oct 2018
- First submitted
- 2 Dec 2015
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual patient data will not be made available
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02621905
- Acronym / sponsor ID
- MPG010
- Conditions
- Neutropenia
- Keywords
- Prophylaxis, Steady-State, Bioavailability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayne Pharma International Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After confirmation of eligibility, participants will be randomly assigned 1:1 to commence therapy with either 100mg mane and 100mg nocte for 21 days or Sporanox 200mg mane and 200mg nocte with food for 21 days. If a subject enters the study already receiving itraconazole prophylaxis at a dose of itraconazole higher than 100 mg twice a day, the subject will then be dosed on study at the pre-study dosage; that is, the subject will take the same number of capsules per day on study as the subject was taking prior to enrolment in the study.
The following information will be collected at baseline; whether the participant is taking itraconazole prophylaxis and at what dose; whether the participant is taking gastric suppression therapy. Patients who are not taking food or who are taking gastric acid suppression therapy (antacids, an H2 antagonist or a proton pump inhibitor) can take Sporanox with cola or orange juice to maximise absorption as recommended in the Sporanox product label (not required for Lozanoc formulation).
At Day 22, participants assigned to
- Lozanoc and who have completed 21 days of Lozanoc prophylaxis will cross over to the same number of Sporanox capsules with food for a further 21 days
- Sporanox and who have completed 21 days of Sporanox prophylaxis will cross over to the same number of Lozanoc capsules for a further 21 days.
The dose of either drug may be dose-reduced or ceased for toxicity at the discretion of the investigator.
During the course of the treatment periods participants will undergo the following assessments:
- 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, chloride, bicarbonate), Liver function tests (bilirubin, albumin, total protein, alanine aminotransferase [ALT], aspartate aminotransferase [AST])
- Pharmacokinetic testing: Trough (pre-morning dose; 0 hr) sample will be collected at Baseline (Day 1), and at Days 8, 15, 22, 29, 36 and 43. Post-dose samples will also be collected 2, 3.5 and 6 hours after the morning dose on Day 22 and Day 43
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sporanox | Active comparator | Drug: Sporanox100 mg |
| Lozanoc | Experimental | Drug: Lozanoc50 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SporanoxAlso: itraconazoleAt least 2 capsules twice a day for 3 weeks | Drug | Sporanox |
| LozanocAlso: itraconazoleAt least 2 capsules twice a day for 3 weeks | Drug | Lozanoc |
Primary outcome
Relative steady-state bioavailability
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
- Individual participant dataSharing planned: No. Individual patient data will not be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Marriott principal investigator
St Vincent's Hospital, Sydney
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sporanox and Lozanoc in people with Neutropenia, run by Mayne Pharma International Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative steady-state bioavailability (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.