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Completed

NCT Number: NCT05488678

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

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.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–82 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Advanced Pharma, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VNRX-7145

Drug

single oral dose

Ceftibuten

Drug

single oral dose

Primary outcomes

  1. Cmax

    Time frame: 0-120 hours post dose

    Maximum plasma concentration, determined directly from individual concentration time data

  2. AUC0-inf

    Time frame: 0-120 hours post dose

    Area under the plasma concentration time curve from time zero extrapolated to infinity based on collected PK

  3. Number of subjects with adverse events

    Time frame: 8 days post dose

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 4, 2022
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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