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Kidney function may affect how new antibiotic combo works

NCT ID NCT05488678

Knowledge-focused Sponsor: Basilea Pharmaceutica Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-stage study tested how a single dose of the antibiotic combination ceftibuten/VNRX-7145 is processed by the body in 32 adults with normal or impaired kidney function, including those on dialysis. Researchers measured drug levels in the blood and monitored safety. The goal was to gather information for future dosing recommendations, not to treat an infection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ceftibuten and VNRX-7145 (an experimental antibiotic combination)
What this could lead to
If successful, this could help doctors understand how to dose this antibiotic safely for patients with kidney problems.
What could go wrong
This is a very early, small study (32 people) focused on drug levels and safety, not on treating an infection. It may not lead to a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

32 people

The number who actually took part.

Started

Oct 2022

Finished

Nov 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 82 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pharmacokinetics

Contacts and locations

Locations

  • Advanced Pharma

    Miami, Florida, 33147, United States

  • Nucleus Network

    Saint Paul, Minnesota, 55114, United States

  • Orlando Clinical Research Center

    Orlando, Florida, 32809, United States

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