PharmacokineticsPhase 1NCT05488678
Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function
A Phase 1 study testing VNRX-7145 and Ceftibuten in people with Pharmacokinetics, run by Basilea Pharmaceutica at 3 sites in United States.
Trial summary
This is an open-label, multicenter, parallel-group study in participants with normal renal function, mild, moderate, or severe renal impairment, or end stage renal disease (ESRD) undergoing standard intermittent dialysis. Read more about this study
- Who is it for?
- Ages 18 to 82 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- VNRX-7145 and Ceftibuten
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Oct 2022to 23 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 82 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults 18-82 years
- Males or non-pregnant, non-lactating females
- Body mass index (BMI): ≥18.5 kg/m2 and ≤40.0 kg/m2
- Laboratory values meeting defined entry criteria
- Subjects with normal renal function (Group 1) must also meet the following criteria:
- Match to one or more participants with renal impairment by gender, age, and BMI
- Subjects with renal impairment (Groups 2-5) must also meet the following criteria:
- Stable, pre-existing renal impairment
Who cannot join
- History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
- Congenital or acquired immunodeficiency syndrome
- Major adverse cardiovascular event within one year of dosing
- Positive alcohol, drug, or tobacco use/test
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Advanced Pharma
Miami, Florida, 33147
Orlando Clinical Research Center
Orlando, Florida, 32809
Nucleus Network
Saint Paul, Minnesota, 55114
About this study
Official title: VNRX-7145-103: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function
This is an open-label, multicenter, parallel-group study in participants with normal renal function, mild, moderate, or severe renal impairment, or end stage renal disease (ESRD) undergoing standard intermittent dialysis. The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.
- Conditions
- Pharmacokinetics
- Being tested
- VNRX-7145, Ceftibuten
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VNRX-7145Drug
single oral dose
CeftibutenDrug
single oral dose
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Control | Experimental | Healthy control participants will be matched by gender, age, and BMI to participants with renal impairment Receives: Drug: VNRX-7145; Drug: Ceftibuten |
| Group 2 - Mild Renal Impairment | Experimental | Mild Renal Impairment Receives: Drug: VNRX-7145; Drug: Ceftibuten |
| Group 3 - Moderate Renal Impairment | Experimental | Moderate Renal Impairment Receives: Drug: VNRX-7145; Drug: Ceftibuten |
| Group 4 - Severe Renal Impairment | Experimental | Severe Renal Impairment Receives: Drug: VNRX-7145; Drug: Ceftibuten |
| Group 5 - End Stage Renal Disease | Experimental | End Stage Renal Disease undergoing chronic intermittent hemodialysis Receives: Drug: VNRX-7145; Drug: Ceftibuten |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration, determined directly from individual concentration time data
Measured: 0-120 hours post dose
AUC0-inf
Area under the plasma concentration time curve from time zero extrapolated to infinity based on collected PK
Measured: 0-120 hours post dose
Number of subjects with adverse events
Measured: 8 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start12 Oct 2022
- Primary completion23 Nov 2023
- Study completion23 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will enroll approximately 32 participants assigned to groups based on renal function.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kamal Hamed, MD, Study director, Basilea Pharmaceutica International Ltd, Allschwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488678
- Sponsor's protocol ID
- VNRX-7145-103
- Other IDs
- 272201600029C-P00026-9999-1
- Status last verified
- Nov 2025
- First submitted
- 3 Aug 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
de Oliveira CF, Lowe K, Fatato P, Marbury T, Litherland K, Engelhardt M, Hamed KA, McGovern PC. Pharmacokinetics, safety, and tolerability of ceftibuten-ledaborbactam etzadroxil in participants with renal impairment. Antimicrob Agents Chemother. 2026 Sep 28:e0086026. doi: 10.1128/aac.00860-26. Online ahead of print.
PubMed 42803753
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VNRX-7145-103: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function
- ClinicalTrials.gov ID
- NCT05488678
- Acronym / sponsor ID
- VNRX-7145-103
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 23 Nov 2023 (actual)
- Study completion
- 23 Nov 2023 (actual)
- First posted
- 4 Aug 2022 (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.
This is an open-label, multicenter, parallel-group study in participants with normal renal function, mild, moderate, or severe renal impairment, or end stage renal disease (ESRD) undergoing standard intermittent dialysis. The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- The study will enroll approximately 32 participants assigned to groups based on renal function.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Control | Experimental | Drug: VNRX-7145, Drug: CeftibutenHealthy control participants will be matched by gender, age, and BMI to participants with renal impairment |
| Group 2 - Mild Renal Impairment | Experimental | Drug: VNRX-7145, Drug: CeftibutenMild Renal Impairment |
| Group 3 - Moderate Renal Impairment | Experimental | Drug: VNRX-7145, Drug: CeftibutenModerate Renal Impairment |
| Group 4 - Severe Renal Impairment | Experimental | Drug: VNRX-7145, Drug: CeftibutenSevere Renal Impairment |
| Group 5 - End Stage Renal Disease | Experimental | Drug: VNRX-7145, Drug: CeftibutenEnd Stage Renal Disease undergoing chronic intermittent hemodialysis |
Who may qualify
- Ages
- 18 to 82 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Healthy adults 18-82 years
- Males or non-pregnant, non-lactating females
- Body mass index (BMI): ≥18.5 kg/m2 and ≤40.0 kg/m2
- Laboratory values meeting defined entry criteria
- Match to one or more participants with renal impairment by gender, age, and BMI
Key exclusion criteria (4 listed)
- History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
- Congenital or acquired immunodeficiency syndrome
- Major adverse cardiovascular event within one year of dosing
- Positive alcohol, drug, or tobacco use/test
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 |
|---|---|---|
| VNRX-7145single oral dose | Drug | Group 1 - Control, Group 2 - Mild Renal Impairment, Group 3 - Moderate Renal Impairment, Group 4 - Severe Renal Impairment, Group 5 - End Stage Renal Disease |
| Ceftibutensingle oral dose | Drug | Group 1 - Control, Group 2 - Mild Renal Impairment, Group 3 - Moderate Renal Impairment, Group 4 - Severe Renal Impairment, Group 5 - End Stage Renal Disease |
Primary outcome
Cmax
Time frame: 0-120 hours post dose
Maximum plasma concentration, determined directly from individual concentration time data
AUC0-inf
Time frame: 0-120 hours post dose
Area under the plasma concentration time curve from time zero extrapolated to infinity based on collected PK
Number of subjects with adverse events
Time frame: 8 days post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Derived from this study: PubMed 42803753de Oliveira CF, Lowe K, Fatato P, Marbury T, Litherland K, Engelhardt M, Hamed KA, McGovern PC. Pharmacokinetics, safety, and tolerability of ceftibuten-ledaborbactam etzadroxil in participants with renal impairment. Antimicrob Agents Chemother. 2026 Sep 28:e0086026. doi: 10.1128/aac.00860-26. Online ahead of print.
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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. This study is not recruiting at the moment.
Kamal Hamed, MD study director
Basilea Pharmaceutica International Ltd, Allschwil
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VNRX-7145 and Ceftibuten in people with Pharmacokinetics, run by Basilea Pharmaceutica at 3 sites in United States.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 0-120 hours post dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05488678, which also lists 1 linked publication.
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 8 Dec 2025.