Hepatic ImpairmentPhase 1NCT04752540
A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
A Phase 1 study testing Olorofim in people with Hepatic Impairment, run by F2G Biotech GmbH at 2 sites in United States.
Trial summary
A single oral dose study to investigate the PK and safety of olorofim in mild and moderately hepatically impaired subjects compared to subjects with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Olorofim
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Jul 2021to 24 Oct 2021
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects 18 to 70 years of age inclusive, at the time of signing the informed consent.
- Body weight ≥50 kg and BMI within the range 18 to 35 kg/m2 (inclusive
- Subjects with mild hepatic impairment will have grade A Child-Pugh score of 5 to 6 at screening and Day -1:
- Subjects with moderate hepatic impairment: will have grade B Child-Pugh score of 7 to 9 at screening and Day -1
- Subjects with normal liver function must be in good health, as determined by a medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations
- Subjects with normal liver function are matched by gender, age (±10 years) and BMI (± 20%) to at least one hepatically impaired subject.
Who cannot join
- Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the Investigator, increases the risk of participating in the study
- Subjects with any history of convulsion (other than childhood febrile convulsion before the age of 6 years).
- Subjects who have any clinically significant allergic disease (excluding mild or seasonal allergies such as contact dermatitis or hay fever) as determined by the Investigator.
- Subjects with a history of or any concomitant active malignancy.
- Subjects with a history of drug or alcohol abuse.
- Subjects with, or with a history of, any clinically significant neurological, renal, cardiovascular, psychiatric, respiratory, metabolic, endocrine, ocular (including minor trauma), hematological, or other major disorders as determined by the Investigator.
- Subjects with signs or symptoms consistent with a COVID-19 infection at screening or Day -1
- Hepatically impaired subjects with liver transplantation, autoimmune liver disease, or drug-induced liver damage
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Orlando Clinical Research Centre
Orlando, Florida, 32809
Orange County Research Centre
Tustin, California, 92780
About this study
Official title: A Phase I, Single-dose, Parallel Group Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
A single oral dose study to investigate the PK and safety of olorofim in mild and moderately hepatically impaired subjects compared to subjects with normal hepatic function.
- Conditions
- Hepatic Impairment
- Being tested
- Olorofim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlorofimDrug
Also called F901318
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Mild hepatic impairment | Experimental | 120 mg olorofim Receives: Drug: Olorofim |
| Moderate hepatic impairment | Experimental | 60 to 120 mg olorofim Receives: Drug: Olorofim |
| Normal hepatic function | Active comparator | 120 mg olorofim Receives: Drug: Olorofim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve From Time Zero to the time of the last quantifiable concentration (AUC 0-t)
Measured: 0-96 hours
Maximum Observed Plasma Concentration (Cmax)
Measured: 0-96 hours
Secondary outcomes (4)
Time to Reach Maximum Plasma Concentration (Tmax)
Measured: 0-96 hours
Apparent Elimination Half Life (t1/2)
Measured: 0-96 hours
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf)
Measured: 0-96 hours
Number of Participants With Treatment-Emergent Adverse Events
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start2 Jul 2021
- Primary completion24 Oct 2021
- Study completion24 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- F2G Biotech GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04752540
- Sponsor's protocol ID
- F901318-01-16
- Status last verified
- Mar 2022
- First submitted
- 11 Feb 2021
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-dose, Parallel Group Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
- ClinicalTrials.gov ID
- NCT04752540
- Acronym / sponsor ID
- F901318-01-16
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- F2G Biotech GmbHIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 24 Oct 2021 (actual)
- Study completion
- 24 Oct 2021 (actual)
- First posted
- 12 Feb 2021 (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 single oral dose study to investigate the PK and safety of olorofim in mild and moderately hepatically impaired subjects compared to subjects with normal hepatic function.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild hepatic impairment | Experimental | Drug: Olorofim120 mg olorofim |
| Moderate hepatic impairment | Experimental | Drug: Olorofim60 to 120 mg olorofim |
| Normal hepatic function | Active comparator | Drug: Olorofim120 mg olorofim |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects 18 to 70 years of age inclusive, at the time of signing the informed consent.
- Body weight ≥50 kg and BMI within the range 18 to 35 kg/m2 (inclusive
- Subjects with mild hepatic impairment will have grade A Child-Pugh score of 5 to 6 at screening and Day -1:
- Subjects with moderate hepatic impairment: will have grade B Child-Pugh score of 7 to 9 at screening and Day -1
- Subjects with normal liver function must be in good health, as determined by a medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations
Key exclusion criteria (8 listed)
- Subjects who have an abnormality in the 12-lead ECG that, in the opinion of the Investigator, increases the risk of participating in the study
- Subjects with any history of convulsion (other than childhood febrile convulsion before the age of 6 years).
- Subjects who have any clinically significant allergic disease (excluding mild or seasonal allergies such as contact dermatitis or hay fever) as determined by the Investigator.
- Subjects with a history of or any concomitant active malignancy.
- Subjects with a history of drug or alcohol abuse.
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 |
|---|---|---|
| OlorofimAlso: F901318single oral dose | Drug | Mild hepatic impairment, Moderate hepatic impairment, Normal hepatic function |
Primary outcome
Area Under the Plasma Concentration-Time Curve From Time Zero to the time of the last quantifiable concentration (AUC 0-t)
Time frame: 0-96 hours
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0-96 hours
4 secondary outcomes
Time to Reach Maximum Plasma Concentration (Tmax)
Time frame: 0-96 hours
Apparent Elimination Half Life (t1/2)
Time frame: 0-96 hours
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf)
Time frame: 0-96 hours
Number of Participants With Treatment-Emergent Adverse Events
Time frame: 10 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 16 Mar 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olorofim in people with Hepatic Impairment, run by F2G Biotech GmbH at 2 sites in United States.
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 6 inclusion and 8 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 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 the Plasma Concentration-Time Curve From Time Zero to the time of the last quantifiable concentration (AUC 0-t) (time frame: 0-96 hours). 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?
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 16 Mar 2022.