Renal ImpairmentPhase 1NCT07758608
Renal Impairment Pharmacokinetics (PK) Trial of Afabicin
A Phase 1 study testing Afabicin Oral and Afabicin IV in people with Renal Impairment, run by Debiopharm International SA at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Afabicin Oral and Afabicin IV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 16 Sep 2026to Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- For participants with mild renal impairment: eGFR ≥60 to <90 mL/min
- For participants with moderate renal impairment: eGFR ≥30 to <60 mL/min
- For participants with severe renal impairment and kidney failure not receiving dialysis: eGFR <30 mL/min
- 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.
Who cannot join
- 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).
- 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.
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- 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.
- History of chronic pancreatitis or idiopathic acute pancreatitis.
- Participants with renal transplant or renal carcinoma (participants with a history of renal carcinoma could be included if cancer free for >10 years).
- A potassium concentration >6.1 millimoles per liter (mmol/L) at screening or Day -1.
- Plasma albumin <3.0 grams per deciliter (g/dL) and/or proteinuria >3.5 grams per day (g/day) at screening.
- A history of nephrotic syndrome.
- Note: Other protocol-specified inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charite Research Organisation
Berlin, 10117
About this study
Official title: An Open-Label, Adaptive Single-Dose Trial to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Afabicin
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.
- Conditions
- Renal Impairment
- Being tested
- Afabicin Oral, Afabicin IV
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afabicin OralDrug
Also called Debio 1450
Tablet
Afabicin IVDrug
Also called Debio 1450
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Drug: Afabicin Oral |
| Group 2 | Experimental | Participants with mild renal impairment: eGFR 60 to less than (<) 90 mL/min will be administered a single dose of afabicin on Day 1. Receives: Drug: Afabicin Oral |
| Group 3 | Experimental | Participants with moderate renal impairment: eGFR 30 to <60 mL/min will be administered a single dose of afabicin on Day 1. Receives: Drug: Afabicin Oral |
| Group 4 | Experimental | 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. Receives: Drug: Afabicin Oral |
| Group 5 | Active comparator | Participants with renal impairment will be administered a single IV dose of afabicin on Day 1. Receives: Drug: Afabicin IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUCinf) of Afabicin Desphosphono
Measured: From predose and at multiple timepoints (up to Day 5) post dose
Secondary outcomes (7)
Maximum Observed Plasma Concentration (Cmax) of Afabicin Desphosphono
Measured: 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
Measured: From predose and at multiple timepoints (up to Day 5) post dose
Time of Maximum Observed Plasma Concentration (tmax) of Afabicin Desphosphono
Measured: From predose and at multiple timepoints (up to Day 5) post dose
Apparent Plasma Terminal Elimination Half-Life (t1/2) of Afabicin Desphosphono
Measured: 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
Measured: From predose and at multiple timepoints (up to Day 5) post dose
Fraction Unbound (fu) of Afabicin Desphosphono
Measured: 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)
Measured: From first dose of the study drug up to the end of the follow-up (up to Day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start16 Sep 2026
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758608
- Sponsor's protocol ID
- Debio 1450-112
- Other IDs
- U1111-1340-5626, 2026-526916-35
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Adaptive Single-Dose Trial to Investigate the Effect of Renal Impairment on the Pharmacokinetics of Afabicin
- ClinicalTrials.gov ID
- NCT07758608
- Acronym / sponsor ID
- Debio 1450-112
- Conditions
- Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Debiopharm International SAIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Afabicin OralParticipants 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. |
| Group 2 | Experimental | Drug: Afabicin OralParticipants with mild renal impairment: eGFR 60 to less than (<) 90 mL/min will be administered a single dose of afabicin on Day 1. |
| Group 3 | Experimental | Drug: Afabicin OralParticipants with moderate renal impairment: eGFR 30 to <60 mL/min will be administered a single dose of afabicin on Day 1. |
| Group 4 | Experimental | Drug: Afabicin OralParticipants 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. |
| Group 5 | Active comparator | Drug: Afabicin IVParticipants with renal impairment will be administered a single IV dose of afabicin on Day 1. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (14 listed)
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afabicin OralAlso: Debio 1450Tablet | Drug | Group 1, Group 2, Group 3, Group 4 |
| Afabicin IVAlso: Debio 1450IV infusion | Drug | Group 5 |
Primary outcome
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
7 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Afabicin Oral and Afabicin IV in people with Renal Impairment, run by Debiopharm International SA at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Debiopharm International S.A (+41 21 321 01 11, clinicaltrials@debiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.