Status:
COMPLETED
A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment
Lead Sponsor:
F2G Biotech GmbH
Conditions:
Renal 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 subjects with severe renal impairment compared to subjects with normal renal 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 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
- 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
Key Trial Info
Start Date :
February 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2022
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05200286
Start Date
February 10 2022
End Date
December 13 2022
Last Update
January 20 2023
Active Locations (1)
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1
Omega Research
Orlando, Florida, United States, 32808