Renal function and afabicin; how kidney health changes drug levels
Official title: An Open-Label, Adaptive Single-Dose Trial to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Afabicin
Run by Debiopharm International SA · NCT07758608 · Data updated 2026-11-12
This trial tests how different levels of kidney function affect the blood levels of afabicin given as a pill or IV after a single dose.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Debiopharm International SA Industry-sponsored |
| Locations | 1 site (Berlin) |
| Status | Recruiting |
| Started | September 16, 2026 |
| Main results expected | December 2027 |
| Study ends | February 2028 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07758608 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with varying levels of renal function (normal to mild impairment) who can provide informed consent, have BMI 18.5–35, are non-smokers, and can adhere to study procedures.
✕Probably not a fit
Individuals with unstable renal function or those unable to comply with study requirements may not benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1 study investigates the pharmacokinetics of afabicin desphosphono in adults with varying renal function who receive a single oral 80 mg or IV 55 mg dose. Participants are grouped by kidney function using eGFR and receive either oral or IV afabicin to see how renal impairment alters absorption, distribution, metabolism, and excretion. The trial aims to characterize exposure and variability to inform dosing in patients with kidney impairment. Enrollment criteria require stable renal function, BMI 18.5–35, non-smoking status, and capacity to comply with study procedures. The study is sponsored by Debiopharm International SA and conducted at Charité Research Organisation in Berlin, with no listed collaborators.
Why it matters
Potential benefit: Understanding how kidney impairment affects afabicin exposure could lead to safer and more effective dosing for patients with reduced kidney function.
How similar studies have gone: Prior pharmacokinetic studies in special populations have informed dosing adjustments for organ impairment; this study extends that approach to afabicin.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed and dated written informed consent obtained before undertaking any trial-specific procedures. 2. Body Mass Index (BMI): 18.5 to 35.0 kilograms per square meter (kg/m\^2), inclusive, at screening. 3. 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. 4. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other trial procedures. 5. 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: 1. For participants with normal renal function: eGFR ≥90 mL/min 2. For participants with mild renal impairment: eGFR ≥60 to \<90 mL/min 3. For participants with moderate renal impairment: eGFR ≥30 to \<60 mL/min 4. For participants with severe renal impairment and kidney failure not receiving dialysis: eGFR \<30 mL/min 6. Confirmation of renal function prior to dosing. Renal function stability must be confirmed on Day -1. The eGFR determined on Day -1, obtained at least 3 days apart from screening, must not deviate by more than 25 percent (%) from the eGFR value obtained at screening. Exclusion Criteria: 1. 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). 2. History of chronic drug or alcohol abuse in the last 4 years. 3. 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. 4. History of investigational medication use within 3 months or 5 half-lives of the drug (whichever is longer) prior to administration the trial drug. 5. Blood loss or donation of blood over 500 milliliter (mL) within 3 months prior to screening. 6. 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. 7. 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. 8. History of uric acid stone disease in the last 5 years. 9. History of chronic pancreatitis or idiopathic acute pancreatitis. 10. Participants with renal transplant or renal carcinoma (participants with a history of renal carcinoma could be included if cancer free for \>10 years). 11. A potassium concentration \>6.1 millimoles per liter (mmol/L) at screening or Day -1. 12. Plasma albumin \<3.0 grams per deciliter (g/dL) and/or proteinuria \>3.5 grams per day (g/day) at screening. 13. A history of nephrotic syndrome. Note: Other protocol-specified inclusion/exclusion criteria may apply.
Where it's running
-
Charite Research Organisation
Berlin, Germany Recruiting
Study contacts
- Study coordinator: Debiopharm International S.A
- Email: clinicaltrials@debiopharm.com
- Phone: +41 21 321 01 11
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.