Renal Impairment Pharmacokinetics (PK) Trial of Afabicin
60 participantsStarted 2026-08
Plain-language summary
The primary purpose of this study is to assess the effect of renal impairment on the PK of afabicin desphosphono after a single oral 80 milligrams (mg) or intravenous (IV) 55 mg dose of afabicin.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed and dated written informed consent obtained before undertaking any trial-specific procedures.
. Body Mass Index (BMI): 18.5 to 35.0 kilograms per square meter (kg/m\^2), inclusive, at screening.
. Nonsmoker (confirmed by urine cotinine \<500 nanograms per milliliter (ng/mL)) and have not used nicotine or nicotine containing products for the last month before screening.
. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures.
. Stable renal function. Renal function must be considered stable by the Investigator. The screening eGFR, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 2021 formula and adjusted for body surface area (multiplied by individual BSA/1.73 m\^2), will be used for group allocation:
. For participants with normal renal function: eGFR ≥90 mL/min
. For participants with mild renal impairment: eGFR ≥60 to \<90 mL/min
. For participants with moderate renal impairment: eGFR ≥30 to \<60 mL/min
Exclusion criteria
. Any clinically significant symptoms of an infectious illness (bacterial, viral or parasitic) within 2 weeks prior to first dosing or a history of recurrent infections (≥3 infections requiring medical intervention in the 6 months prior to ICF signature).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Afabicin Desphosphono
Timeframe: From predose and at multiple timepoints (up to Day 5) post dose
. History of chronic drug or alcohol abuse in the last 4 years.
. A positive result in the alcohol and/or urine drug abuse evaluations at screening or admission on Day -1, unless the result is attributable to a prescribed medication used to treat comorbidities associated with chronic kidney disease or another stable condition.
. History of investigational medication use within 3 months or 5 half-lives of the drug (whichever is longer) prior to administration the trial drug.
. Blood loss or donation of blood over 500 milliliter (mL) within 3 months prior to screening.
. Uncontrolled hypertension, defined as systolic blood pressure greater than (\>)160 millimeters of mercury (mm Hg) or diastolic blood pressure \>100 mm Hg on average of 3 measurements at screening. Screening measurements should be conducted with participants on baseline anti-hypertensive regimen.
. History and/or presence of any clinically significant disease or disorder, such as cardiovascular, pulmonary, renal (for participants with normal renal function), hepatic, neurological, gastrointestinal, endocrine, psychiatric or mental disease or disorder, or mental or legal incapacitation, which, in the opinion of the Investigator, may either put the participant at risk due to participation in the trial, influence the results of the trial, or influence the participant's ability to participate in the trial.
. History of uric acid stone disease in the last 5 years.