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

F2G Biotech

Status and phase

Completed

Phase 1

Conditions

Renal Impairment

Treatments

Drug: Olorofim

Study type

Interventional

Funder types

Industry

Identifiers

NCT05200286

F901318-01-17

Details and patient eligibility

About

A single oral dose study to investigate the PK and safety of olorofim in subjects with severe renal impairment compared to subjects with normal renal function.

Enrollment

16 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 severe renal impairment (or End-Stage Renal Disease who are not on dialysis) and with an eGFR <30 mL/min, estimated using the Cockcroft-Gault equation at screening and Day -1
Subjects with normal renal 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 renal function are matched by gender, age (±10 years) and BMI (± 20%) to at least one renally 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, hepatic, 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
Renally impaired subjects with kidney transplantation, or on dialysis