Renal Impairment
Conditions
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.
Interventions
DRUGOlorofim
Single oral dose
Sponsors
F2G Biotech GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to the time of the last quantifiable concentration (AUC 0-t) | 0-96 hours |
| Maximum Observed Plasma Concentration (Cmax) | 0-96 hours |
Secondary
| Measure | Time frame |
|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax) | 0-96 hours |
| Apparent Elimination Half Life (t1/2) | 0-96 hours |
| Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) | 0-96 hours |
| Number of Participants With Treatment-Emergent Adverse Events | 10 days |
Countries
United States
Outcome results
None listed