A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment

F2G Biotech

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: Olorofim

Study type: Interventional

Funder types: Industry

Identifiers

NCT04752540

F901318-01-16

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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 design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

Mild hepatic impairment

Experimental group

Description:

120 mg olorofim

Treatment:

Drug: Olorofim

Moderate hepatic impairment

Experimental group

Description:

60 to 120 mg olorofim

Treatment:

Drug: Olorofim

Normal hepatic function

Active Comparator group

Description:

120 mg olorofim

Treatment:

Drug: Olorofim