Healthy SubjectsPhase 1NCT04877379
VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers
A Phase 1 study testing VNRX-7145 and VNRX-5024 (ceftibuten) in people with Healthy Subjects, run by Basilea Pharmaceutica at 1 site in Netherlands.
Trial summary
This study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 (ceftibuten) when administered as single agents and with co-administration in a single dose cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- VNRX-7145 and VNRX-5024 (ceftibuten)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Jun 2021to 10 Nov 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults 18-55 years
- Males or non-pregnant, non-lactating females
- Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
- Normal blood pressure
- Normal lab tests
Who cannot join
- History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
- History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
- Use of antacid medications
- Abnormal ECG or history of clinically significant abnormal rhythm disorder
- Positive alcohol, drug, or tobacco use/test
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
PRA Health Sciences - Early Development Services
Groningen
About this study
Official title: VNRX-7145-102: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics (PK) of VNRX-7145 and VNRX-5024 (Ceftibuten) in Healthy Adult Volunteers
This study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 (ceftibuten) when administered as single agents and with co-administration in a single dose cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days. VNRX-7145 and VNRX-5024 (ceftibuten) will be administered every 8 hours (q8h) for 10 days at 2 dose levels of VNRX-7145 in Part 3.
- Conditions
- Healthy Subjects
- Being tested
- VNRX-7145, VNRX-5024 (ceftibuten), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VNRX-7145Drug
β-lactamase inhibitor
VNRX-5024 (ceftibuten)Drug
β-lactam antibiotic
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Subjects will receive single doses of VNRX-7145 or VNRX-5024 alone and in combination. All subjects will receive study drug in the sequence specified by the randomization schedule. Receives: Drug: VNRX-7145; Drug: VNRX-5024 (ceftibuten) |
| Part 2A | Experimental | Multiple dose administration of VNRX-7145 q8h for 10 days Receives: Drug: VNRX-7145 |
| Part 2B | Placebo comparator | Multiple dose administration of placebo q8h for 10 days Receives: Drug: Placebo |
| Part 3A | Experimental | Multiple dose administration of low dose VNRX-7145 + VNRX-5024 Receives: Drug: VNRX-7145; Drug: VNRX-5024 (ceftibuten) |
| Part 3B | Experimental | Multiple dose administration of high dose VNRX-7145 + VNRX-5024 Receives: Drug: VNRX-7145; Drug: VNRX-5024 (ceftibuten) |
| Part 3C | Placebo comparator | Multiple dose administration of Placebo (matching VNRX-7145 + VNRX-5024) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Cmax
concentration time data
Measured: 0-48 hours
Part 1: AUC0-inf
Area under the concentration-time curve from time-zero extrapolated to infinity based on collected PK
Measured: 0-48 hours
Parts 2&3: Number of subjects with adverse events
Measured: Day 15 (+2)
Secondary outcomes (5)
Part 1: Number of subjects with adverse events
Measured: Day 14 (+2)
Parts 2&3: AUC0-tau
Measured: Day 1
Parts 2&3: AUC0-tau
Measured: Day 10
Parts 2&3: Cmax
Measured: Day 1
Parts 2&3: Cmax
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start8 Jun 2021
- Primary completion10 Nov 2021
- Study completion10 Nov 2021
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 Healthy SubjectsStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- Part 1: Crossover Parts 2\&3: Parallel
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 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
- NCT04877379
- Sponsor's protocol ID
- VNRX-7145-102
- Other IDs
- 272201600029C-P00007-9999-2
- Status last verified
- Nov 2025
- First submitted
- 3 May 2021
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
de Oliveira CF, Dorr MB, van de Wetering J, Lowe K, Sabato P, Winchell G, Chen H, McGovern PC. Safety and pharmacokinetics of single and multiple doses of ledaborbactam etzadroxil with or without ceftibuten in healthy volunteers. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0021025. doi: 10.1128/aac.00210-25. Epub 2025 Aug 5.
PubMed 40762486
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-7145-102: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics (PK) of VNRX-7145 and VNRX-5024 (Ceftibuten) in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT04877379
- Acronym / sponsor ID
- VNRX-7145-102
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 7 May 2021 (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 study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 (ceftibuten) when administered as single agents and with co-administration in a single dose cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days. VNRX-7145 and VNRX-5024 (ceftibuten) will be administered every 8 hours (q8h) for 10 days at 2 dose levels of VNRX-7145 in Part 3.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Part 1: Crossover Parts 2\&3: Parallel
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: VNRX-7145, Drug: VNRX-5024 (ceftibuten)Subjects will receive single doses of VNRX-7145 or VNRX-5024 alone and in combination. All subjects will receive study drug in the sequence specified by the randomization schedule. |
| Part 2A | Experimental | Drug: VNRX-7145Multiple dose administration of VNRX-7145 q8h for 10 days |
| Part 2B | Placebo comparator | Drug: PlaceboMultiple dose administration of placebo q8h for 10 days |
| Part 3A | Experimental | Drug: VNRX-7145, Drug: VNRX-5024 (ceftibuten)Multiple dose administration of low dose VNRX-7145 + VNRX-5024 |
| Part 3B | Experimental | Drug: VNRX-7145, Drug: VNRX-5024 (ceftibuten)Multiple dose administration of high dose VNRX-7145 + VNRX-5024 |
| Part 3C | Placebo comparator | Drug: PlaceboMultiple dose administration of Placebo (matching VNRX-7145 + VNRX-5024) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adults 18-55 years
- Males or non-pregnant, non-lactating females
- Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
- Normal blood pressure
- Normal lab tests
Key exclusion criteria (5 listed)
- History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
- History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
- Use of antacid medications
- Abnormal ECG or history of clinically significant abnormal rhythm disorder
- 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-7145β-lactamase inhibitor | Drug | Part 1, Part 2A, Part 3A, Part 3B |
| VNRX-5024 (ceftibuten)β-lactam antibiotic | Drug | Part 1, Part 3A, Part 3B |
| PlaceboPlacebo | Drug | Part 2B, Part 3C |
Primary outcome
Part 1: Cmax
Time frame: 0-48 hours
concentration time data
Part 1: AUC0-inf
Time frame: 0-48 hours
Area under the concentration-time curve from time-zero extrapolated to infinity based on collected PK
Parts 2&3: Number of subjects with adverse events
Time frame: Day 15 (+2)
5 secondary outcomes
Part 1: Number of subjects with adverse events
Time frame: Day 14 (+2)
Parts 2&3: AUC0-tau
Time frame: Day 1
Parts 2&3: AUC0-tau
Time frame: Day 10
Parts 2&3: Cmax
Time frame: Day 1
Parts 2&3: Cmax
Time frame: Day 10
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 40762486de Oliveira CF, Dorr MB, van de Wetering J, Lowe K, Sabato P, Winchell G, Chen H, McGovern PC. Safety and pharmacokinetics of single and multiple doses of ledaborbactam etzadroxil with or without ceftibuten in healthy volunteers. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0021025. doi: 10.1128/aac.00210-25. Epub 2025 Aug 5.
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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
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 VNRX-7145 and VNRX-5024 (ceftibuten) in people with Healthy Subjects, run by Basilea Pharmaceutica at 1 site in Netherlands.
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 5 inclusion and 5 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 1 site in Netherlands. 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. Some participants in this study may receive a placebo. 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?
Part 1: Cmax (time frame: 0-48 hours). 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 NCT04877379, 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.