A Phase 1 interventional study of Afabicin Oral and Afabicin IV in Renal Impairment, sponsored by Debiopharm International SA. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Debiopharm International SA (part of Debiopharm) · Phase 1, Interventional, and Treatment
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.
1,409 studies on the registry are indexed under Renal Insufficiency; 143 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 1,058 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Debiopharm International SA is the lead sponsor of 51 studies on the registry; 6 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Stable renal function. Renal function must be considered stable by the Investigator. The screening , 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:
Exclusion Criteria:
Note: Other protocol-specified inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with normal renal function: estimated Glomerular Filtration Rate (eGFR) greater than or equal to (≥) 90 milliliters per minute (mL/min) will be administered a single dose of afabicin on Day 1.
Drug: Afabicin Oral
Participants with mild renal impairment: eGFR 60 to less than (\<) 90 mL/min will be administered a single dose of afabicin on Day 1.
Drug: Afabicin Oral
Participants with moderate renal impairment: eGFR 30 to \<60 mL/min will be administered a single dose of afabicin on Day 1.
Drug: Afabicin Oral
Participants with severe renal impairment and kidney failure not receiving dialysis: eGFR \<30 mL/min will be administered a single dose of afabicin on Day 1.
Drug: Afabicin Oral
Participants with renal impairment will be administered a single IV dose of afabicin on Day 1.
Drug: Afabicin IV
Tablet
Also known as: Debio 1450
IV infusion
Also known as: Debio 1450
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Afabicin Desphosphono
Time frame: From predose and at multiple timepoints (up to Day 5) post dose
Maximum Observed Plasma Concentration (Cmax) of Afabicin Desphosphono
Time frame: From predose and at multiple timepoints (up to Day 5) post dose
Area Under the Plasma Concentration-Time Curve to the Last Quantifiable Concentration (AUClast) of Afabicin Desphosphono
Time frame: From predose and at multiple timepoints (up to Day 5) post dose
Time of Maximum Observed Plasma Concentration (tmax) of Afabicin Desphosphono
Time frame: From predose and at multiple timepoints (up to Day 5) post dose
Apparent Plasma Terminal Elimination Half-Life (t1/2) of Afabicin Desphosphono
Time frame: From predose and at multiple timepoints (up to Day 5) post dose
Apparent Total Body Clearance From the Plasma (Cl/F or Cl) of Afabicin Desphosphono
Time frame: From predose and at multiple timepoints (up to Day 5) post dose
Fraction Unbound (fu) of Afabicin Desphosphono
Time frame: From predose and at multiple timepoints (up to Day 5) post dose
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (TEAE)
Time frame: From first dose of the study drug up to the end of the follow-up (up to Day 10)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Afabicin