PharmacokineticsPhase 1NCT05527834
Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants
A Phase 1 study testing VNRX-7145 and Ceftibuten in people with Pharmacokinetics, run by Basilea Pharmaceutica at 1 site in United States.
Trial summary
This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). 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… Read more about this study
- Who is it for?
- Ages 18 to 65 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
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2022to 10 Feb 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults 18-65 years
- Males or non-pregnant, non-lactating females
- Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
- Laboratory values meeting defined entry criteria
Who cannot join
- History of drug allergy or hypersensitivity to penicillin, cephalosporin, or β-lactam antibacterial drug
- Conditions that potentially alter absorption and/or excretion of orally administered drugs
- Congenital or acquired immunodeficiency syndrome
- Positive alcohol, drug, or tobacco use/test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VNRX-7145-104: an Open-label, Cross-over Study to Evaluate the Effect of Food on the Pharmacokinetics, Safety, and Tolerability of Ceftibuten/VNRX-7145 in Healthy Participants.
This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). 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 |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1 will assess the impact of a high fat meal. Receives: Drug: VNRX-7145; Drug: Ceftibuten |
| Cohort 2 | Experimental | Cohort 2 will be conducted to assess the impact of an alternative lower fat meal if administration with high fat meal has a food effect on drug exposure. Receives: Drug: VNRX-7145; Drug: Ceftibuten |
| Cohort 3 | Experimental | Cohort 3 will evaluate realistic fasting intervals and/or additional meal types if administration with food has a food effect on drug exposure. 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 observed plasma concentration (Cmax)
Measured: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
AUC0-t
Area under the plasma concentration-time curve (AUC) from time 0 up to the last quantifiable concentration at time t (AUC0-t)
Measured: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
AUC0-inf
AUC from time 0 extrapolated to infinity (AUC0-inf)
Measured: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start13 Sep 2022
- Primary completion6 Feb 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT05527834
- Sponsor's protocol ID
- VNRX-7145-104
- Other IDs
- 272201600029C-P00017-9999-1
- Status last verified
- Nov 2025
- First submitted
- 1 Sep 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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-7145-104: an Open-label, Cross-over Study to Evaluate the Effect of Food on the Pharmacokinetics, Safety, and Tolerability of Ceftibuten/VNRX-7145 in Healthy Participants.
- ClinicalTrials.gov ID
- NCT05527834
- Acronym / sponsor ID
- VNRX-7145-104
- Conditions
- Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 6 Sep 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, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: VNRX-7145, Drug: CeftibutenCohort 1 will assess the impact of a high fat meal. |
| Cohort 2 | Experimental | Drug: VNRX-7145, Drug: CeftibutenCohort 2 will be conducted to assess the impact of an alternative lower fat meal if administration with high fat meal has a food effect on drug exposure. |
| Cohort 3 | Experimental | Drug: VNRX-7145, Drug: CeftibutenCohort 3 will evaluate realistic fasting intervals and/or additional meal types if administration with food has a food effect on drug exposure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults 18-65 years
- Males or non-pregnant, non-lactating females
- Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
- Laboratory values meeting defined entry criteria
Key exclusion criteria (4 listed)
- History of drug allergy or hypersensitivity to penicillin, cephalosporin, or β-lactam antibacterial drug
- Conditions that potentially alter absorption and/or excretion of orally administered drugs
- Congenital or acquired immunodeficiency syndrome
- 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 | Cohort 1, Cohort 2, Cohort 3 |
| CeftibutenSingle oral dose | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Cmax
Time frame: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
Maximum observed plasma concentration (Cmax)
AUC0-t
Time frame: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
Area under the plasma concentration-time curve (AUC) from time 0 up to the last quantifiable concentration at time t (AUC0-t)
AUC0-inf
Time frame: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
AUC from time 0 extrapolated to infinity (AUC0-inf)
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.
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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 Ceftibuten in people with Pharmacokinetics, run by Basilea Pharmaceutica at 1 site 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 4 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 1 site 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 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects). 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?
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.