NeutropeniaPhase 2NCT02755857
Bioavailability Study of Lozanoc™ 65 mg Itraconazole Capsules in Patients Requiring Prophylaxis
A Phase 2 study testing Lozanoc in people with Neutropenia, run by Mayne Pharma International Pty Ltd at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neutropenia
- What is being tested?
- Lozanoc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2016to Jan 2017
- Phase
- Phase 2
- 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 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Lozanoc
- Keywords
- Prophylaxis, Bioavailability, Pharmacokinetics
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LozanocDrug
Also called itraconazole
65 mg
| Study group | Role | What they receive |
|---|---|---|
| Lozanoc | Experimental | 65 mg, capsules, at least 2 capsules twice a day Receives: Drug: Lozanoc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steady-state plasma itraconazole concentrations
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 posted29 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2016
- Study completionJan 2017
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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayne Pharma International Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deborah Marriott, MBBS BSc(MED) FRACP FRCPA, Principal investigator, St Vincent's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755857
- Sponsor's protocol ID
- MPG011
- Status last verified
- Oct 2018
- First submitted
- 28 Apr 2016
- 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
- A Single-arm, Multiple-Dose, Steady-State, Bioavailability Study With Twice Daily Dosing of Lozanoc™ (65 mg Itraconazole Capsules, Mayne) Taken Regardless of Food
- ClinicalTrials.gov ID
- NCT02755857
- Acronym / sponsor ID
- MPG011
- Conditions
- Neutropenia
- Keywords
- Prophylaxis, Bioavailability, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayne Pharma International Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 29 Apr 2016 (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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lozanoc | Experimental | Drug: Lozanoc65 mg, capsules, at least 2 capsules twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- At least 21 days of prior dosing with oral itraconazole, either Lozanoc 50mg capsules twice daily or Sporanox 100mg capsules twice daily.
Key exclusion criteria (10 listed)
- 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:
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 |
|---|---|---|
| LozanocAlso: itraconazole65 mg | Drug | Lozanoc |
Primary outcome
Steady-state plasma itraconazole concentrations
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, MBBS BSc(MED) FRACP FRCPA principal investigator
St Vincent's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 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 9 inclusion and 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Steady-state plasma itraconazole concentrations (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.