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

NCT05488678 | Completed Phase 1 FDA Drug

• 2 other identifiers: VNRX-7145-103272201600029C-P00026-9999-1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

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.

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (5)

Group 1 - Control

EXPERIMENTAL

Healthy control participants will be matched by gender, age, and BMI to participants with renal impairment

Drug: VNRX-7145; Drug: Ceftibuten

Group 2 - Mild Renal Impairment

EXPERIMENTAL

Mild Renal Impairment

Drug: VNRX-7145; Drug: Ceftibuten

Group 3 - Moderate Renal Impairment

EXPERIMENTAL

Moderate Renal Impairment

Drug: VNRX-7145; Drug: Ceftibuten

Group 4 - Severe Renal Impairment

EXPERIMENTAL

Severe Renal Impairment

Drug: VNRX-7145; Drug: Ceftibuten

Group 5 - End Stage Renal Disease

EXPERIMENTAL

End Stage Renal Disease undergoing chronic intermittent hemodialysis

Drug: VNRX-7145; Drug: Ceftibuten

Interventions

VNRX-7145 DRUG

single oral dose

Group 1 - Control; Group 2 - Mild Renal Impairment; Group 3 - Moderate Renal Impairment; Group 4 - Severe Renal Impairment; Group 5 - End Stage Renal Disease

Ceftibuten DRUG

single oral dose

Group 1 - Control; Group 2 - Mild Renal Impairment; Group 3 - Moderate Renal Impairment; Group 4 - Severe Renal Impairment; Group 5 - End Stage Renal Disease

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Basilea Pharmaceutica: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (3)

Advanced Pharma

Miami, Florida, 33147, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Interventions

Ceftibuten

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kamal Hamed, MD

  Basilea Pharmaceutica International Ltd, Allschwil

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: August 4, 2022
• Study Start: October 12, 2022
• Primary Completion: November 23, 2023
• Study Completion: November 23, 2023
• Last Updated: December 8, 2025

Record last verified: 2025-11

Locations

US (3)