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

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.

Study Overview

• Status: Completed
• Conditions: Pharmacokinetics
• Intervention / Treatment: Drug: VNRX-7145; Drug: Ceftibuten

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33147
      • Advanced Pharma
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 - Control; Healthy control participants will be matched by gender, age, and BMI to participants with renal impairment	Drug: VNRX-7145; single oral dose; Drug: Ceftibuten; single oral dose
Experimental: Group 2 - Mild Renal Impairment; Mild Renal Impairment	Drug: VNRX-7145; single oral dose; Drug: Ceftibuten; single oral dose
Experimental: Group 3 - Moderate Renal Impairment; Moderate Renal Impairment	Drug: VNRX-7145; single oral dose; Drug: Ceftibuten; single oral dose
Experimental: Group 4 - Severe Renal Impairment; Severe Renal Impairment	Drug: VNRX-7145; single oral dose; Drug: Ceftibuten; single oral dose
Experimental: Group 5 - End Stage Renal Disease; End Stage Renal Disease undergoing chronic intermittent hemodialysis	Drug: VNRX-7145; single oral dose; Drug: Ceftibuten; single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum plasma concentration, determined directly from individual concentration time data	0-120 hours post dose
AUC0-inf	Area under the plasma concentration time curve from time zero extrapolated to infinity based on collected PK	0-120 hours post dose
Number of subjects with adverse events		8 days post dose

Collaborators and Investigators

• Sponsor: Basilea Pharmaceutica
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Director: Kamal Hamed, MD, Basilea Pharmaceutica International Ltd, Allschwil

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2022
• Primary Completion (Actual): November 23, 2023
• Study Completion (Actual): November 23, 2023

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amides; beta-Lactams; Lactams; Cephalosporins; Thiazines; Ceftibuten
• Other Study ID Numbers: VNRX-7145-103; 272201600029C-P00026-9999-1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No