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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05488678

Enrollment

Registered

2022-08-04

Start date

2022-10-12

Completion date

2023-11-23

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics

Brief 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. 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.

Interventions

DRUGVNRX-7145

single oral dose

DRUGCeftibuten

single oral dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

The study will enroll approximately 32 participants assigned to groups based on renal function.

Eligibility

Sex/Gender

ALL

Age

18 Years to 82 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Cmax	0-120 hours post dose	Maximum plasma concentration, determined directly from individual concentration time data
AUC0-inf	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	8 days post dose	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026