Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function

Completed · Phase 1

Conditions studied: Pharmacokinetics

In brief

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.

Key facts

Study ID

NCT05488678

Run by

Basilea Pharmaceutica

People needed

32

Starts

2022-10-12

Expected to finish

2023-11-23

Last updated by the study team

2025-12-08

Who can join

Age: 18 and older, up to 82. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Advanced Pharma — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• Nucleus Network — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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