Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
F2G Biotech GmbH
Age
18–70
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
