Invasive AspergillosisPhase 1NCT03340597
Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects
A Phase 1 study testing F901318 in people with Invasive Aspergillosis, run by F2G Ltd at 1 site in United Kingdom.
Trial summary
A Phase I, open label study evaluating safety, tolerability and pharmacokinetics of F901318 in healthy subjects following up to 28 days dosing, where F901318 is given orally . The effect of food upon the pharmacokinetics of F901318 and the effect of F901318 upon the pharmacokinetics of midazolam will also be assessed. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Invasive Aspergillosis
- What is being tested?
- F901318
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Dec 2017to 13 Apr 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be males or females of any ethnic origin between 18 and 55 years of age, weighing between 60 and 100 kg, with a body mass index (BMI) between 18 and 30 kg/m2.
- 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 not acceptable)
- Male subjects and female subjects of childbearing potential must agree to use appropriate contraception from screening, during the study and for 3 months after the last dose of study drug
Who cannot join
- Female subjects who are pregnant or lactating.
- Subjects who have received any prescribed systemic or topical medication (other than hormonal contraception or hormone replacement therapy) 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) 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical Research Unit
Leeds, West Yorkshire
About this study
Official title: A Phase I, Open Label Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of Varying Oral Dosing Regimens for F901318
A Phase I, open label study evaluating safety, tolerability and pharmacokinetics of F901318 in healthy subjects following up to 28 days dosing, where F901318 is given orally . The effect of food upon the pharmacokinetics of F901318 and the effect of F901318 upon the pharmacokinetics of midazolam will also be assessed.
Read the detailed description
Each cohort will comprise 12 healthy subjects and cohorts A1 (A2), B1 and B2 will be conducted in a sequential manner such that the dose level can be optimised upon review of emerging safety, tolerability and PK data.
- Conditions
- Invasive Aspergillosis
- Being tested
- F901318
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F901318Drug
F901318 tablet
| Study group | Role | What they receive |
|---|---|---|
| A1; F901318 (10 days) | Experimental | F901318 : 10 days dosing orally Receives: Drug: F901318 |
| A2; F901318 | Experimental | F901318 : 10 days dosing orally, alternative dosing regimen Receives: Drug: F901318 |
| A3; F901318 | Experimental | F901318 : 10 days dosing orally, alternative dosing regimen Receives: Drug: F901318 |
| A4; F901318 | Experimental | F901318 : 10 days dosing orally, alternative dosing regimen Receives: Drug: F901318 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events
safety and tolerability
Measured: 18 days
Secondary outcomes (3)
Area under the curve (AUC) 0-tau for F901318
Pharmacokinetics (PK) of oral doses of F90318
Measured: 11 days
maximum plasma concentration (Cmax) for F901318
PK of oral doses of F90318
Measured: 11 days
minimum plasma concentration (Cmin) for F901318
PK of oral doses of F90318
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start12 Dec 2017
- Primary completion13 Apr 2018
- Study completion13 Apr 2018
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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- F2G Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
- Investigators
- Jim Bush, MB ChB PhD MRCS FFPM, Principal investigator, Covance CRU Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340597
- Sponsor's protocol ID
- F901318-01-13-17
- Status last verified
- Jul 2018
- First submitted
- 9 Nov 2017
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of Varying Oral Dosing Regimens for F901318
- ClinicalTrials.gov ID
- NCT03340597
- Acronym / sponsor ID
- F901318-01-13-17
- Conditions
- Invasive Aspergillosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- F2G LtdIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 13 Apr 2018 (actual)
- First posted
- 13 Nov 2017 (actual)
- 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.
A Phase I, open label study evaluating safety, tolerability and pharmacokinetics of F901318 in healthy subjects following up to 28 days dosing, where F901318 is given orally . The effect of food upon the pharmacokinetics of F901318 and the effect of F901318 upon the pharmacokinetics of midazolam will also be assessed.
Detailed description
Each cohort will comprise 12 healthy subjects and cohorts A1 (A2), B1 and B2 will be conducted in a sequential manner such that the dose level can be optimised upon review of emerging safety, tolerability and PK data.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1; F901318 (10 days) | Experimental | Drug: F901318F901318 : 10 days dosing orally |
| A2; F901318 | Experimental | Drug: F901318F901318 : 10 days dosing orally, alternative dosing regimen |
| A3; F901318 | Experimental | Drug: F901318F901318 : 10 days dosing orally, alternative dosing regimen |
| A4; F901318 | Experimental | Drug: F901318F901318 : 10 days dosing orally, alternative dosing regimen |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects will be males or females of any ethnic origin between 18 and 55 years of age, weighing between 60 and 100 kg, with a body mass index (BMI) between 18 and 30 kg/m2.
- 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 not acceptable)
- Male subjects and female subjects of childbearing potential must agree to use appropriate contraception from screening, during the study and for 3 months after the last dose of study drug
Key exclusion criteria (4 listed)
- Female subjects who are pregnant or lactating.
- Subjects who have received any prescribed systemic or topical medication (other than hormonal contraception or hormone replacement therapy) 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) 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.
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 |
|---|---|---|
| F901318F901318 tablet | Drug | A1; F901318 (10 days), A2; F901318, A3; F901318, A4; F901318 |
Primary outcome
Incidence of treatment emergent adverse events
Time frame: 18 days
safety and tolerability
3 secondary outcomes
Area under the curve (AUC) 0-tau for F901318
Time frame: 11 days
maximum plasma concentration (Cmax) for F901318
Time frame: 11 days
minimum plasma concentration (Cmin) for F901318
Time frame: 11 days
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 2 Aug 2018.
- 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: No
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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.
Jim Bush, MB ChB PhD MRCS FFPM principal investigator
Covance CRU Ltd
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 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 3 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 2 Aug 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 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?
Incidence of treatment emergent adverse events (time frame: 18 days). 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 NCT03340597, 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 2 Aug 2018.