Invasive AspergillosisPhase 1NCT02730442
Study of Potential for Interaction of Fluconazole With F901318
A Phase 1 study testing F901318 and Fluconazole in people with Invasive Aspergillosis, run by F2G Ltd at 1 site in United Kingdom.
Trial summary
This will be an open label study in two parts. In the first part, F901318 (dose 2 mg/kg IV over 4 hours, Day 1) will be followed by F901318 (2 mg/kg IV over 4 hours) given on Day 8, after dosing with fluconazole 800 mg daily for 1 day (Day 4) and 400 mg daily orally for 4 days (Days 5 to 8). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Invasive Aspergillosis
- What is being tested?
- F901318 and Fluconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will be males and females of any ethnic origin aged between 18 and 45 years of age and weighing 50-100 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.
Who cannot join
- Male and female 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 18 +/- 2 (Part 1) or Day 15 +/- 2 (Part 2), 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 Drug/Drug Interactions Between F901318 and Fluconazole
This will be an open label study in two parts. In the first part, F901318 (dose 2 mg/kg IV over 4 hours, Day 1) will be followed by F901318 (2 mg/kg IV over 4 hours) given on Day 8, after dosing with fluconazole 800 mg daily for 1 day (Day 4) and 400 mg daily orally for 4 days (Days 5 to 8). Up to twenty subjects will be included in two cohorts which will undergo the same dosing schedules of fluconazole 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 F901318 kinetics detectable before and after dosing with fluconazole 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. In this cohort, based on the pharmacokinetic findings in cohort 1, the dose of F901318 may be increased to up to 4 mg/kg to establish a dose suitable for phase 2 evaluation. PK sampling for plasma F901318 will continue from before the first dose up to and including 72 hours after dosing. PK sampling for fluconazole will continue from before the first dose and up to 72 hours after the fifth 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 F901318 and the fifth dose of fluconazole.
The second part of the study will take place if no appreciable change in the pharmacokinetics of either F901318 or fluconazole has been observed in either the first or the second cohorts in the first part of the study. This second part will enrol 12 subjects. These subjects will receive fluconazole 800 mg daily for one day (Day 1) and 400 mg daily orally for 4 days (Days 2 to 5) in combination with F901318 which will be given in a dose of up to 4 mg/kg IV bid for one day (Day 1) followed by 7 doses of intravenous F901318 up to 2.5 mg/kg bid (Days 2 to 5). Pharmacokinetic profiles of F901318 and fluconazole will be obtained during dosing and over a 72-hour period following the final dose of both compounds.
Read the detailed description
Part 1
Treatment Period (Day -1 to Day 11; visit 2):
Subjects will be admitted to the clinical unit in the afternoon of Day -1 and will remain on site until completion of the 72-hour post fluconazole and F901318 dose study-related procedures on Day 11. Admission procedures (Day -1) include a review of inclusion/exclusion criteria, weight, vital signs, test for drugs of abuse, alcohol and smoking and pregnancy where appropriate (must be negative), and a review of concomitant medication and adverse events. Blood (haematology, clinical chemistry and coagulation function) and urine (urinalysis) will be obtained for safety evaluations. Breakfast will be taken 30-60 minutes prior to dosing)
Days 1 - 4: F901318 (2 mg/kg IV for cohort 1 and up to 4 mg/kg IV for cohort 2) over 4 hours will be administered on Day 1. Blood samples for determination of plasma levels of F901318 will be collected predose and at the following time points up to 72 hours post-dose:
1, 2, 3, 4, 4.25, 4.5, 5, 6, 8, 10, 12, 16, 20, 24, 38, 48, 72 hours
Blood pressure, and pulse (lying and standing), and core temperature will be recorded at the following times on Day 1:
Prior to dosing, 1, 2, 4, 6, 8, 12 and 24 hours following dosing.
Twelve lead ECGs will be recorded prior to dosing and 1, 4, 8, 12 and 24 hours after dosing with F901318.
Telemetry will be set up 1 hour prior to dosing with F901318 and will continue for 12 hours thereafter. It may be extended to 24 hours at the discretion of the investigator.
Day 4 to Day 7: After an overnight fast from midnight, fluconazole will be administered in a dose of 800 mg on day 4 and 400 mg daily on Days 5-7 in the morning.
On Day 4, pharmacokinetic blood samples will be drawn for fluconazole estimation at the following times in relation to dosing:
-5 minutes, 15, 30, 45, 60, 75, 90, 120 min. 3, 4, 6, 8, 10, 12, 16, 20 hours.
Blood samples for determination of peak (4 hours) and trough (predose) plasma levels of fluconazole will be collected on Days 5 to 7 inclusive. Dosing on these days will be before breakfast is taken.
Vital signs (supine and standing pulse rate and blood pressure and oral temperature) will be recorded prior to dosing on Day 4 and at the following times thereafter:
1, 4, 8, 12, 24, 48 hours
12 lead ECGs will be recorded prior to dosing on Day 4 and at the following times thereafter:
24, 48 hours.
Fasting blood samples will be obtained for haematology, coagulation and clinical chemistry prior to dosing with fluconazole on Day 4 and at the following time points:
48 hours
A spot urine sample will be obtained for urinalysis prior to dosing with fluconazole on Day 4 and at the following time points:
48 hours
Days 8-11: Subjects will fast for 12 hours before dosing on Day 8. Water will be allowed ad libitum. Blood samples for determination of baseline plasma levels of fluconazole and F901318 blank and safety laboratory analyses (clinical chemistry, haematology and coagulation function) will be collected pre-dose on Day 8. F901318 (2 mg/kg IV for cohort 1 and up to 4 mg/kg IV for cohort 2) will be administered intravenously over 4 hours in the morning. Fluconazole will be administered orally on Day 8 at the same time as the start of the infusion. Blood samples for determination of plasma levels of fluconazole will be collected at the following time points after the dose of fluconazole:
15, 30, 45, 60, 75, 90 min, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hours.
Blood samples for plasma concentrations of F901318 will be collected at the following times after the start of the infusion (assuming an infusion duration of 4 hours).
1, 2, 3, 4, 4.25, 4.5, 5, 6, 8, 10, 12, 16, 20, 24, 38, 48, 72 hours
Blood pressure, and pulse (lying and standing) and core temperature will be recorded at the following times on Day 8:
- 2, 4, 6, 8, 12 and 24, 48, 72 hours following the start of dosing with F901318. Twelve lead ECGs will be recorded at 1, 4, 8, 12, 24, 48, 72 hours after dosing with F901318. Telemetry will be commenced 1 hour prior to dosing with F901318 and will continue for 12 hours thereafter. This monitoring may be extended to 24 hours at the discretion of the Principal Investigator. Adverse events and concomitant medications will be recorded throughout. Subjects will be discharged after all 72 hours measurements and observations have been completed, so long as they are fit to leave in the opinion of the Investigator. Post Study Visit: (visit 3) After discharge on Day 11, all subjects will return to the study centre on days 16-20 to complete a post study follow-up visit. Total blood loss for each subject in this part of the study will be 202 mL approximately. Part 2 Treatment Period (Day -1 to Day 8; visit 3): Subjects will be admitted to the clinical unit in the afternoon of Day -1 and will remain on site until completion of the 72-hour post fluconazole and F901318 dose study-related procedures on Day 8. Admission procedures (Day -1) include a review of inclusion/exclusion criteria, weight, vital signs, test for drugs of abuse, alcohol and smoking and pregnancy where appropriate (must be negative) and a review of concomitant medication and adverse events. Blood (haematology, clinical chemistry and coagulation function) and urine (urinalysis) will be obtained for safety evaluations. Subjects will fast from midnight. Day 1: F901318 up to 4 mg/kg IV over 4 hours bid will be administered starting at time 0 and fluconazole 800 mg orally at time 0. A second dose of F901318 (up to 4 mg/kg IV over 4 hours) will be given starting at 12 hours post the morning dose. Water will be allowed ad libitum. Blood samples for determination of plasma levels of F901318 will be collected predose and at the following time points:
- 4, 4.25, 4.5, 5, 6, 8, 10, 12 (just before second infusion), 16 (5 minutes before end of infusion) hours.
Pharmacokinetic blood samples will be drawn for fluconazole estimation pre-dose at the following times after dosing:
15, 30, 45, 60, 75, 90, 120 min. 3, 4, 6, 8, 10, 12, 16, 20 hours.
Blood pressure, and pulse (lying and standing), and oral temperature will be recorded at the following times on Day 1:
Prior to dosing, 1, 2, 4, 6, 8 and 12 hours following dosing.
Twelve lead ECGs will be recorded prior to dosing and 1, 4, 8, and 12 hours after dosing.
Telemetry will be set up 1 hour prior to dosing with F901318 and will continue for 12 hours thereafter. This monitoring may be extended to 24 hours at the discretion of the Principal Investigator.
Local tolerability will be determined prior to dosing with F901318 and at the end of each infusion.
Day 2 to Day 8: F901318 will be administered intravenously twice daily (7 doses of up to 2.5 mg/kg each infused over 4 hours) (Days 2 to 5).
Fluconazole will be administered after fasting from 12 midnight in a dose of 400 mg daily in the morning for 4 doses (Days 2 to 5).
Blood samples for determination of peak (4 hours) and trough (predose) plasma levels of fluconazole and F901318 (prior to start of infusion and 5 minutes before end of infusion) will be collected on Days 2 to 4 inclusive.
Vital signs (supine and standing pulse rate and blood pressure, core temperature and local tolerability) will be recorded prior to and at the end of each infusion on Days 2, 3 and 4
12 lead ECGs will be recorded prior to morning dosing on Days 2, 3, 4 and 5
Fasting blood samples will be obtained for haematology, coagulation and clinical chemistry prior to dosing with fluconazole on Days 2, 5 and on Day 8 (72 hours after the last doses of F901318 and fluconazole).
A spot urine sample will be obtained for urinalysis prior to dosing with fluconazole on Days 2, 5 and on Day 8 (72 hours after the last doses of F901318 and fluconazole).
On Day 5, pharmacokinetic blood samples will be drawn for F901318 estimation at the following times in relation to dosing:
-5 minutes, 2, 4, 4.25, 4.5, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hours.
On Day 5, pharmacokinetic blood samples will be drawn for fluconazole estimation at the following times in relation to dosing:
-5 minutes, 15, 30, 45, 60, 75, 90, 120 min. 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hours.
Vital signs and local tolerability will be obtained prior to dosing on Day 5 and at the end of the F901318 infusion.
Telemetry will be set up 1 hour prior to dosing with F901318 on Day 5 and will continue for 12 hours thereafter. This monitoring may be extended to 24 hours at the discretion of the Principal Investigator.
Day 8: An ophthalmology assessment will be performed. Subjects will be discharged from the Unit following collection of the final assessments and blood samples and completion of the ophthalmology assessment.
Adverse events and concomitant medications will be recorded throughout.
Post Study Visit (visit 4):
After discharge on Day 8, all subjects will return to the study centre on days 13-17 to complete a post study follow-up visit.
Total blood loss for each subject in this part of the study will be 224 mL approximately.
- Conditions
- Invasive Aspergillosis
- Being tested
- F901318, Fluconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F901318Drug
Also called Antifungal agent
Administration of F901318 intravenously
FluconazoleDrug
Also called Antifungal agent
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Single dose F901318 with fluconazole | Experimental | AUC0-t for F901318 will be assessed before and after 5 days of treatment with fluconazole oral Receives: Drug: F901318; Drug: Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent adverse events
Adverse events
Measured: 5 days
Secondary outcomes (1)
Pharmacokinetics area under concentration/time curve 0-t
Area under concentration time curve 0-t
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startFeb 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
- Celerion Ltd
- Responsible party
- Sponsor
- Investigators
- A Stewart, Principal investigator, Celerion Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02730442
- Sponsor's protocol ID
- F01318-01-05-15
- Status last verified
- Apr 2016
- First submitted
- 1 Apr 2016
- Last updated
- 2 Feb 2017
- Results posted
- No
- Data monitoring committee
- 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 Feb 2017. 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 Drug/Drug Interactions Between F901318 and Fluconazole
- ClinicalTrials.gov ID
- NCT02730442
- Acronym / sponsor ID
- F01318-01-05-15
- Conditions
- Invasive Aspergillosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- F2G LtdIndustry (pharma, biotech, devices)
- Collaborators
- Celerion Ltd
- Study start
- Feb 2016 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 6 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 will be an open label study in two parts. In the first part, F901318 (dose 2 mg/kg IV over 4 hours, Day 1) will be followed by F901318 (2 mg/kg IV over 4 hours) given on Day 8, after dosing with fluconazole 800 mg daily for 1 day (Day 4) and 400 mg daily orally for 4 days (Days 5 to 8). Up to twenty subjects will be included in two cohorts which will undergo the same dosing schedules of fluconazole 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 F901318 kinetics detectable before and after dosing with fluconazole 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. In this cohort, based on the pharmacokinetic findings in cohort 1, the dose of F901318 may be increased to up to 4 mg/kg to establish a dose suitable for phase 2 evaluation. PK sampling for plasma F901318 will continue from before the first dose up to and including 72 hours after dosing. PK sampling for fluconazole will continue from before the first dose and up to 72 hours after the fifth 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 F901318 and the fifth dose of fluconazole.
The second part of the study will take place if no appreciable change in the pharmacokinetics of either F901318 or fluconazole has been observed in either the first or the second cohorts in the first part of the study. This second part will enrol 12 subjects. These subjects will receive fluconazole 800 mg daily for one day (Day 1) and 400 mg daily orally for 4 days (Days 2 to 5) in combination with F901318 which will be given in a dose of up to 4 mg/kg IV bid for one day (Day 1) followed by 7 doses of intravenous F901318 up to 2.5 mg/kg bid (Days 2 to 5). Pharmacokinetic profiles of F901318 and fluconazole will be obtained during dosing and over a 72-hour period following the final dose of both compounds.
Detailed description
Part 1
Treatment Period (Day -1 to Day 11; visit 2):
Subjects will be admitted to the clinical unit in the afternoon of Day -1 and will remain on site until completion of the 72-hour post fluconazole and F901318 dose study-related procedures on Day 11. Admission procedures (Day -1) include a review of inclusion/exclusion criteria, weight, vital signs, test for drugs of abuse, alcohol and smoking and pregnancy where appropriate (must be negative), and a review of concomitant medication and adverse events. Blood (haematology, clinical chemistry and coagulation function) and urine (urinalysis) will be obtained for safety evaluations. Breakfast will be taken 30-60 minutes prior to dosing)
Days 1 - 4: F901318 (2 mg/kg IV for cohort 1 and up to 4 mg/kg IV for cohort 2) over 4 hours will be administered on Day 1. Blood samples for determination of plasma levels of F901318 will be collected predose and at the following time points up to 72 hours post-dose:
1, 2, 3, 4, 4.25, 4.5, 5, 6, 8, 10, 12, 16, 20, 24, 38, 48, 72 hours
Blood pressure, and pulse (lying and standing), and core temperature will be recorded at the following times on Day 1:
Prior to dosing, 1, 2, 4, 6, 8, 12 and 24 hours following dosing.
Twelve lead ECGs will be recorded prior to dosing and 1, 4, 8, 12 and 24 hours after dosing with F901318.
Telemetry will be set up 1 hour prior to dosing with F901318 and will continue for 12 hours thereafter. It may be extended to 24 hours at the discretion of the investigator.
Day 4 to Day 7: After an overnight fast from midnight, fluconazole will be administered in a dose of 800 mg on day 4 and 400 mg daily on Days 5-7 in the morning.
On Day 4, pharmacokinetic blood samples will be drawn for fluconazole estimation at the following times in relation to dosing:
-5 minutes, 15, 30, 45, 60, 75, 90, 120 min. 3, 4, 6, 8, 10, 12, 16, 20 hours.
Blood samples for determination of peak (4 hours) and trough (predose) plasma levels of fluconazole will be collected on Days 5 to 7 inclusive. Dosing on these days will be before breakfast is taken.
Vital signs (supine and standing pulse rate and blood pressure and oral temperature) will be recorded prior to dosing on Day 4 and at the following times thereafter:
1, 4, 8, 12, 24, 48 hours
12 lead ECGs will be recorded prior to dosing on Day 4 and at the following times thereafter:
24, 48 hours.
Fasting blood samples will be obtained for haematology, coagulation and clinical chemistry prior to dosing with fluconazole on Day 4 and at the following time points:
48 hours
A spot urine sample will be obtained for urinalysis prior to dosing with fluconazole on Day 4 and at the following time points:
48 hours
Days 8-11: Subjects will fast for 12 hours before dosing on Day 8. Water will be allowed ad libitum. Blood samples for determination of baseline plasma levels of fluconazole and F901318 blank and safety laboratory analyses (clinical chemistry, haematology and coagulation function) will be collected pre-dose on Day 8. F901318 (2 mg/kg IV for cohort 1 and up to 4 mg/kg IV for cohort 2) will be administered intravenously over 4 hours in the morning. Fluconazole will be administered orally on Day 8 at the same time as the start of the infusion. Blood samples for determination of plasma levels of fluconazole will be collected at the following time points after the dose of fluconazole:
15, 30, 45, 60, 75, 90 min, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hours.
Blood samples for plasma concentrations of F901318 will be collected at the following times after the start of the infusion (assuming an infusion duration of 4 hours).
1, 2, 3, 4, 4.25, 4.5, 5, 6, 8, 10, 12, 16, 20, 24, 38, 48, 72 hours
Blood pressure, and pulse (lying and standing) and core temperature will be recorded at the following times on Day 8:
- 2, 4, 6, 8, 12 and 24, 48, 72 hours following the start of dosing with F901318. Twelve lead ECGs will be recorded at 1, 4, 8, 12, 24, 48, 72 hours after dosing with F901318. Telemetry will be commenced 1 hour prior to dosing with F901318 and will continue for 12 hours thereafter. This monitoring may be extended to 24 hours at the discretion of the Principal Investigator. Adverse events and concomitant medications will be recorded throughout. Subjects will be discharged after all 72 hours measurements and observations have been completed, so long as they are fit to leave in the opinion of the Investigator. Post Study Visit: (visit 3) After discharge on Day 11, all subjects will return to the study centre on days 16-20 to complete a post study follow-up visit. Total blood loss for each subject in this part of the study will be 202 mL approximately. Part 2 Treatment Period (Day -1 to Day 8; visit 3): Subjects will be admitted to the clinical unit in the afternoon of Day -1 and will remain on site until completion of the 72-hour post fluconazole and F901318 dose study-related procedures on Day 8. Admission procedures (Day -1) include a review of inclusion/exclusion criteria, weight, vital signs, test for drugs of abuse, alcohol and smoking and pregnancy where appropriate (must be negative) and a review of concomitant medication and adverse events. Blood (haematology, clinical chemistry and coagulation function) and urine (urinalysis) will be obtained for safety evaluations. Subjects will fast from midnight. Day 1: F901318 up to 4 mg/kg IV over 4 hours bid will be administered starting at time 0 and fluconazole 800 mg orally at time 0. A second dose of F901318 (up to 4 mg/kg IV over 4 hours) will be given starting at 12 hours post the morning dose. Water will be allowed ad libitum. Blood samples for determination of plasma levels of F901318 will be collected predose and at the following time points:
- 4, 4.25, 4.5, 5, 6, 8, 10, 12 (just before second infusion), 16 (5 minutes before end of infusion) hours.
Pharmacokinetic blood samples will be drawn for fluconazole estimation pre-dose at the following times after dosing:
15, 30, 45, 60, 75, 90, 120 min. 3, 4, 6, 8, 10, 12, 16, 20 hours.
Blood pressure, and pulse (lying and standing), and oral temperature will be recorded at the following times on Day 1:
Prior to dosing, 1, 2, 4, 6, 8 and 12 hours following dosing.
Twelve lead ECGs will be recorded prior to dosing and 1, 4, 8, and 12 hours after dosing.
Telemetry will be set up 1 hour prior to dosing with F901318 and will continue for 12 hours thereafter. This monitoring may be extended to 24 hours at the discretion of the Principal Investigator.
Local tolerability will be determined prior to dosing with F901318 and at the end of each infusion.
Day 2 to Day 8: F901318 will be administered intravenously twice daily (7 doses of up to 2.5 mg/kg each infused over 4 hours) (Days 2 to 5).
Fluconazole will be administered after fasting from 12 midnight in a dose of 400 mg daily in the morning for 4 doses (Days 2 to 5).
Blood samples for determination of peak (4 hours) and trough (predose) plasma levels of fluconazole and F901318 (prior to start of infusion and 5 minutes before end of infusion) will be collected on Days 2 to 4 inclusive.
Vital signs (supine and standing pulse rate and blood pressure, core temperature and local tolerability) will be recorded prior to and at the end of each infusion on Days 2, 3 and 4
12 lead ECGs will be recorded prior to morning dosing on Days 2, 3, 4 and 5
Fasting blood samples will be obtained for haematology, coagulation and clinical chemistry prior to dosing with fluconazole on Days 2, 5 and on Day 8 (72 hours after the last doses of F901318 and fluconazole).
A spot urine sample will be obtained for urinalysis prior to dosing with fluconazole on Days 2, 5 and on Day 8 (72 hours after the last doses of F901318 and fluconazole).
On Day 5, pharmacokinetic blood samples will be drawn for F901318 estimation at the following times in relation to dosing:
-5 minutes, 2, 4, 4.25, 4.5, 5, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hours.
On Day 5, pharmacokinetic blood samples will be drawn for fluconazole estimation at the following times in relation to dosing:
-5 minutes, 15, 30, 45, 60, 75, 90, 120 min. 3, 4, 6, 8, 10, 12, 16, 20, 24, 36, 48, 72 hours.
Vital signs and local tolerability will be obtained prior to dosing on Day 5 and at the end of the F901318 infusion.
Telemetry will be set up 1 hour prior to dosing with F901318 on Day 5 and will continue for 12 hours thereafter. This monitoring may be extended to 24 hours at the discretion of the Principal Investigator.
Day 8: An ophthalmology assessment will be performed. Subjects will be discharged from the Unit following collection of the final assessments and blood samples and completion of the ophthalmology assessment.
Adverse events and concomitant medications will be recorded throughout.
Post Study Visit (visit 4):
After discharge on Day 8, all subjects will return to the study centre on days 13-17 to complete a post study follow-up visit.
Total blood loss for each subject in this part of the study will be 224 mL approximately.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single dose F901318 with fluconazole | Experimental | Drug: F901318, Drug: FluconazoleAUC0-t for F901318 will be assessed before and after 5 days of treatment with fluconazole oral |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects will be males and females of any ethnic origin aged between 18 and 45 years of age and weighing 50-100 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.
Key exclusion criteria (4 listed)
- Male and female 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 18 +/- 2 (Part 1) or Day 15 +/- 2 (Part 2), 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 |
|---|---|---|
| F901318Also: Antifungal agentAdministration of F901318 intravenously | Drug | Single dose F901318 with fluconazole |
| FluconazoleAlso: Antifungal agentOral administration | Drug | Single dose F901318 with fluconazole |
Primary outcome
Treatment emergent adverse events
Time frame: 5 days
Adverse events
1 secondary outcome
Pharmacokinetics area under concentration/time curve 0-t
Time frame: 5 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 Feb 2017.
- 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
Related trials for Invasive Aspergillosis
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
RecruitingObservational study
Fungal Status and Prognosis in ABPA
ABPA, Allergic Bronchopulmonary Aspergillosis
RecruitingObservational study
Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score
Pneumonia, Fungal Pneumonia
RecruitingObservational study
A Cohort Study of the Efficacy and Safety of Biologics in Patients With ABPA
ABPA, Biologics
Active, not recruitingObservational study
Liver Cirrhosis Patients With Invasive Pulmonary Aspergillosis: in Depth Understanding Clinical Host Risk Factors
Liver Cirrhosis, Viral Pneumonia
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.
A Stewart principal investigator
Celerion 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 and Fluconazole 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 Feb 2017. 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?
Treatment emergent adverse events (time frame: 5 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 NCT02730442, 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 Feb 2017.