HealthyPhase 1NCT04171739
Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim
A Phase 1 study testing Itraconazole oral solution, Rifampicin Oral Capsule and Olorofim in people with Healthy, run by F2G Ltd at 1 site in United Kingdom.
Trial summary
This is a Phase 1, single-centre, fixed-sequence, open label, drug-drug interaction study in 2 groups of healthy subjects. Group A: to evaluate the effects of itraconazole, a strong inhibitor of cytochrome P450 3A (CYP3A), upon the pharmacokinetics of olorofim . Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Itraconazole oral solution, Rifampicin Oral Capsule and Olorofim
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Nov 2019to 11 Feb 2020
- 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
- males or females of any ethnic origin between 18 and 55 years of age
- subjects weighing between 50 and 100 kg, with a body mass index (BMI) between 18 and 32 kg/m2.
- subjects in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations
Who cannot join
- Female subjects of child-bearing potential.
- Male subjects (or their partners) who are not willing to use appropriate contraception during the study and for 3 months after end of dosing.
- Female subjects who are pregnant or lactating.
- Subjects who have received any prescribed systemic or topical medication within 14 days of first dose administration
- Subjects who have used any non-prescribed systemic or topical medication within 7 days of first dose administration
- Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of first dose administration
- Subjects with or history of clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatry, respiratory, metabolic, endocrine, ocular haematological or other major disorders as determined by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open Label Study in Healthy Subjects to Evaluate the Effect of Itraconazole and Rifampicin Upon the Pharmacokinetics of a Single Oral Dose of Olorofim.
This is a Phase 1, single-centre, fixed-sequence, open label, drug-drug interaction study in 2 groups of healthy subjects.
Group A: to evaluate the effects of itraconazole, a strong inhibitor of cytochrome P450 3A (CYP3A), upon the pharmacokinetics of olorofim .
Group B: t o evaluate the effects rifampicin, a strong inducer of CYP3A, upon the pharmacokinetics of olorofim .
- Conditions
- Healthy
- Being tested
- Itraconazole oral solution, Rifampicin Oral Capsule, Olorofim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itraconazole oral solutionDrug
200 mg once daily on Days 6 to 15
Rifampicin Oral CapsuleDrug
600 mg once daily on Days 6 to 15
OlorofimDrug
Also called F901318
Single oral dose on Days 1 and 11
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Other | Itraconazole DDI Receives: Drug: Itraconazole oral solution; Drug: Olorofim |
| Cohort B | Other | Rifampicin DDI Receives: Drug: Rifampicin Oral Capsule; Drug: Olorofim |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum plasma concentration (Cmax) for olorofim.
Measured: 16 days
Area under the concentration-time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim.
Measured: 16 days
Secondary outcomes (4)
Time to Cmax (Tmax) of olorofim
Measured: 16 days
area under the concentration-time curve to infinity (AUC0-∞) for olorofim
Measured: 16 days
terminal elimination half-life (t½) for olorofim
Measured: 16 days
Number of subjects with treatment-related adverse events
Measured: 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start18 Nov 2019
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
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 HealthyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- F2G Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research
- Responsible party
- Sponsor
- Investigators
- Adeep Puri, Principal investigator, Hammersmith Medicines Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171739
- Sponsor's protocol ID
- F901318-01-15
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 24 Jul 2020
- 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 24 Jul 2020. 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 Effect of Itraconazole and Rifampicin Upon the Pharmacokinetics of a Single Oral Dose of Olorofim.
- ClinicalTrials.gov ID
- NCT04171739
- Acronym / sponsor ID
- F901318-01-15
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- F2G LtdIndustry (pharma, biotech, devices)
- Collaborators
- Hammersmith Medicines Research
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 21 Nov 2019 (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.
This is a Phase 1, single-centre, fixed-sequence, open label, drug-drug interaction study in 2 groups of healthy subjects.
Group A: to evaluate the effects of itraconazole, a strong inhibitor of cytochrome P450 3A (CYP3A), upon the pharmacokinetics of olorofim .
Group B: t o evaluate the effects rifampicin, a strong inducer of CYP3A, upon the pharmacokinetics of olorofim .
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Other | Drug: Itraconazole oral solution, Drug: OlorofimItraconazole DDI |
| Cohort B | Other | Drug: Rifampicin Oral Capsule, Drug: OlorofimRifampicin DDI |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- males or females of any ethnic origin between 18 and 55 years of age
- subjects weighing between 50 and 100 kg, with a body mass index (BMI) between 18 and 32 kg/m2.
- subjects in good health, as determined by a medical history, physical examination, 12-lead electrocardiogram (ECG) and clinical laboratory evaluations
Key exclusion criteria (7 listed)
- Female subjects of child-bearing potential.
- Male subjects (or their partners) who are not willing to use appropriate contraception during the study and for 3 months after end of dosing.
- Female subjects who are pregnant or lactating.
- Subjects who have received any prescribed systemic or topical medication within 14 days of first dose administration
- Subjects who have used any non-prescribed systemic or topical medication within 7 days of first dose administration
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 |
|---|---|---|
| Itraconazole oral solution200 mg once daily on Days 6 to 15 | Drug | Cohort A |
| Rifampicin Oral Capsule600 mg once daily on Days 6 to 15 | Drug | Cohort B |
| OlorofimAlso: F901318Single oral dose on Days 1 and 11 | Drug | Cohort A, Cohort B |
Primary outcome
maximum plasma concentration (Cmax) for olorofim.
Time frame: 16 days
Area under the concentration-time curve to time of last quantifiable concentration (AUC0-tlast) for olorofim.
Time frame: 16 days
4 secondary outcomes
Time to Cmax (Tmax) of olorofim
Time frame: 16 days
area under the concentration-time curve to infinity (AUC0-∞) for olorofim
Time frame: 16 days
terminal elimination half-life (t½) for olorofim
Time frame: 16 days
Number of subjects with treatment-related adverse events
Time frame: 23 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 24 Jul 2020.
- 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.
Adeep Puri 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 Itraconazole oral solution, Rifampicin Oral Capsule and Olorofim in people with Healthy, 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 7 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 24 Jul 2020. 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?
maximum plasma concentration (Cmax) for olorofim. (time frame: 16 days). The study lists 2 primary outcomes in all. 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 NCT04171739, 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 24 Jul 2020.