Invasive AspergillosisPhase 1NCT02680808
Evaluation of the Potential for Cytochrome P450 3A4 Inhibition by F901318 Using Oral Midazolam as a Probe
A Phase 1 study testing Midazolam with F901318 in people with Invasive Aspergillosis, run by F2G Ltd at 1 site in United Kingdom.
Trial summary
Open label evaluation of potential interaction of F901318 with cytochrome P450 3A4 using midazolam as a probe. Twenty healthy male subjects will participate Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Invasive Aspergillosis
- What is being tested?
- Midazolam with F901318
- 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 siteUnited Kingdom
- Study dates
- Jan 2016to Jun 2016
- Phase
- Phase 1
- 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 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be males of any ethnic origin between 18 and 45 years of age and weighing 60-100 kg inclusive.
- Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is acceptable).
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
- Subjects must have ophthalmology assessments within the normal limits at screening. This includes normal Meibomian gland function.
Who cannot join
- Male subjects who are not willing to use appropriate contraception during the study and for three months thereafter.
- Subjects who have received any prescribed systemic or topical medication within 14 days of the dose administration unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
- Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the dose administration (with the exception of vitamin/mineral supplements and paracetamol) unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
- Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the dose administration unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety. For at least 2 weeks prior to dosing and until all blood samples and observations are completed on Day 15 +/- 2s, subjects will not be allowed to eat any food or drink any beverage containing alcohol, grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family e.g. kale, broccoli, watercress, spring greens, kohlrabi, Brussels sprouts, mustard and charbroiled meats.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study in Healthy Volunteers to Evaluate the Potential for Cytochrome P450 3A4 Inhibition by F901318 Using Oral Midazolam as a Probe
Open label evaluation of potential interaction of F901318 with cytochrome P450 3A4 using midazolam as a probe. Twenty healthy male subjects will participate
Read the detailed description
This will be an open label study of midazolam (dose 2 mg orally, Day 1) followed by midazolam (2 mg orally) given after dosing with intravenous F901318 4 mg/kg bid for one day followed by 2.5 mg/kg bid for 7 doses (Day 7). Up to twenty subjects will be included in two cohorts which will undergo the same dosing schedules of midazolam and F901318 and undergo the same procedures. The first cohort will consist of 12 subjects studied in two groups of six subjects each. If there is clearly a difference in midazolam kinetics detectable between the first and second doses of midazolam, in this first cohort, the second cohort will not be studied. If there is no clear difference, the second cohort will also be studied to give a final result. PK sampling for midazolam and 1- and 4-hydroxymidazolam plasma and urine concentrations will continue for up to and including 24 hours after dosing with midazolam on both occasions. PK sampling for F901318 will continue from before the first dose and up to 24 hours after the ninth dose. A follow up visit will be conducted 7 +/- 2 days after discharge from the clinical unit following completion of blood sampling following the second dose of midazolam and the ninth dose of F901318.
- Conditions
- Invasive Aspergillosis
- Being tested
- Midazolam with F901318
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam with F901318Drug
Pharmacokinetics of midazolam with F901318
| Study group | Role | What they receive |
|---|---|---|
| midazolam with F901318 | Experimental | Pharmacokinetic profile of midazolam 2 mg orally when given after dosing with F901318 to steady state. Receives: Drug: Midazolam with F901318 |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under concentration/time curve
AUC0-24
Measured: 24 hours
Secondary outcomes (1)
safety and tolerability as assessed by number of treatment related adverse events
adverse events
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive AspergillosisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- F2G Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research
- Responsible party
- Sponsor
- Investigators
- FRANS VANDENBERG, Principal investigator, Hammersmith Medicines Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680808
- Sponsor's protocol ID
- F901318.01.04.15
- Status last verified
- Jun 2016
- First submitted
- 28 Jan 2016
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Cornelissen K, Rex JH, Zinzi D, Law D, Upcott Gill R, Jones HM, Maertens J, Chen SC-A, Bruggemann R. Evaluation of the cytochrome P450-mediated drug interaction profile of olorofim. Antimicrob Agents Chemother. 2026 Jun 3;70(6):e0174525. doi: 10.1128/aac.01745-25. Epub 2026 Apr 20.
PubMed 42008658
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study in Healthy Volunteers to Evaluate the Potential for Cytochrome P450 3A4 Inhibition by F901318 Using Oral Midazolam as a Probe
- ClinicalTrials.gov ID
- NCT02680808
- Acronym / sponsor ID
- F901318.01.04.15
- Conditions
- Invasive Aspergillosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- F2G LtdIndustry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Feb 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.
Open label evaluation of potential interaction of F901318 with cytochrome P450 3A4 using midazolam as a probe. Twenty healthy male subjects will participate
Detailed description
This will be an open label study of midazolam (dose 2 mg orally, Day 1) followed by midazolam (2 mg orally) given after dosing with intravenous F901318 4 mg/kg bid for one day followed by 2.5 mg/kg bid for 7 doses (Day 7). Up to twenty subjects will be included in two cohorts which will undergo the same dosing schedules of midazolam and F901318 and undergo the same procedures. The first cohort will consist of 12 subjects studied in two groups of six subjects each. If there is clearly a difference in midazolam kinetics detectable between the first and second doses of midazolam, in this first cohort, the second cohort will not be studied. If there is no clear difference, the second cohort will also be studied to give a final result. PK sampling for midazolam and 1- and 4-hydroxymidazolam plasma and urine concentrations will continue for up to and including 24 hours after dosing with midazolam on both occasions. PK sampling for F901318 will continue from before the first dose and up to 24 hours after the ninth dose. A follow up visit will be conducted 7 +/- 2 days after discharge from the clinical unit following completion of blood sampling following the second dose of midazolam and the ninth dose of F901318.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| midazolam with F901318 | Experimental | Drug: Midazolam with F901318Pharmacokinetic profile of midazolam 2 mg orally when given after dosing with F901318 to steady state. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects will be males of any ethnic origin between 18 and 45 years of age and weighing 60-100 kg inclusive.
- Subjects must be in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations (congenital non haemolytic hyperbilirubinaemia is acceptable).
- Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions.
- Subjects must have ophthalmology assessments within the normal limits at screening. This includes normal Meibomian gland function.
Key exclusion criteria (4 listed)
- Male subjects who are not willing to use appropriate contraception during the study and for three months thereafter.
- Subjects who have received any prescribed systemic or topical medication within 14 days of the dose administration unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
- Subjects who have used any non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the dose administration (with the exception of vitamin/mineral supplements and paracetamol) unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety.
- Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the dose administration unless in the opinion of the Investigator and the Medical Monitor the medication will not interfere with the study procedures or compromise safety. For at least 2 weeks prior to dosing and until all blood samples and observations are completed on Day 15 +/- 2s, subjects will not be allowed to eat any food or drink any beverage containing alcohol, grapefruit or grapefruit juice, apple or orange juice, vegetables from the mustard green family e.g. kale, broccoli, watercress, spring greens, kohlrabi, Brussels sprouts, mustard and charbroiled meats.
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 |
|---|---|---|
| Midazolam with F901318Pharmacokinetics of midazolam with F901318 | Drug | midazolam with F901318 |
Primary outcome
area under concentration/time curve
Time frame: 24 hours
AUC0-24
1 secondary outcome
safety and tolerability as assessed by number of treatment related adverse events
Time frame: 24 hours
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 9 Jun 2016.
- Derived from this study: PubMed 42008658Cornelissen K, Rex JH, Zinzi D, Law D, Upcott Gill R, Jones HM, Maertens J, Chen SC-A, Bruggemann R. Evaluation of the cytochrome P450-mediated drug interaction profile of olorofim. Antimicrob Agents Chemother. 2026 Jun 3;70(6):e0174525. doi: 10.1128/aac.01745-25. Epub 2026 Apr 20.
- Individual participant dataSharing planned: Undecided
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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.
FRANS VANDENBERG principal investigator
Hammersmith Medicines Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Midazolam with F901318 in people with Invasive Aspergillosis, run by F2G Ltd at 1 site in United Kingdom.
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 4 inclusion and 4 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 9 Jun 2016. 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 United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
area under concentration/time curve (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02680808, which also lists 1 linked publication.
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 9 Jun 2016.