Status:
COMPLETED
A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
Lead Sponsor:
F2G Biotech GmbH
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
July 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04752540
Start Date
July 2 2021
End Date
October 24 2021
Last Update
March 16 2022
Active Locations (2)
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1
Orange County Research Centre
Tustin, California, United States, 92780
2
Orlando Clinical Research Centre
Orlando, Florida, United States, 32809