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

• Status: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: F2G Biotech GmbH
• Treatments: Olorofim

Criteria

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