ClinicalTrials.gg
RecruitingNCT07758608Updated Oct 26, 2026

Renal Impairment Pharmacokinetics (PK) Trial of Afabicin

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

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 26, 2026Now RecruitingSite recruiting status changedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Impairment

Browse trials for

03

In context

Renal Insufficiency

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Signed and dated written obtained before undertaking any trial-specific procedures.
  2. (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 , 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

Exclusion Criteria:

  1. Any 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 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.

Terms in these criteria, in plain language(5)

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.

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.

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.

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.

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.

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Group 1

    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

  • Experimental
    Group 2

    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

  • Experimental
    Group 3

    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

  • Experimental
    Group 4

    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

  • Active comparator
    Group 5

    Participants with renal impairment will be administered a single IV dose of afabicin on Day 1.

    Drug: Afabicin IV

Interventions

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Afabicin Desphosphono

    Time frame: From predose and at multiple timepoints (up to Day 5) post dose

  2. 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

  3. Time of Maximum Observed Plasma Concentration (tmax) of Afabicin Desphosphono

    Time frame: From predose and at multiple timepoints (up to Day 5) post dose

  4. 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

  5. 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

  6. Fraction Unbound (fu) of Afabicin Desphosphono

    Time frame: From predose and at multiple timepoints (up to Day 5) post dose

  7. 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)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 26, 2026
Sites
Charite Research Organisation is now Recruiting
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Not yet recruiting→Recruiting
    Charite Research Organisation is now Recruiting
    + 2 other changes: verification date and date precision

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 ↗

10

Registry details

Key details

Study ID
NCT07758608
Responsible party
Sponsor
First posted
Aug 11, 2026
Start date
Sep 16, 2026
Primary completion
Dec 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
Oct 26, 2026

Study contacts

Debiopharm International S.A
Contact
clinicaltrials@debiopharm.com
+41 21 321 01 11

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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