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

Phase 1

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: VNRX-7145; Drug: Ceftibuten

• Registration Number: NCT05488678
• Lead Sponsor: Venatorx Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-04
• Study Start: 2022-10-12
• Primary Completion: 2023-11-21
• Study Completion: 2023-11-21
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 - Control	VNRX-7145	Healthy control participants will be matched by gender, age, and BMI to participants with renal impairment
Group 1 - Control	Ceftibuten	Healthy control participants will be matched by gender, age, and BMI to participants with renal impairment
Group 4 - Severe Renal Impairment	VNRX-7145	Severe Renal Impairment
Group 4 - Severe Renal Impairment	Ceftibuten	Severe Renal Impairment
Group 2 - Mild Renal Impairment	Ceftibuten	Mild Renal Impairment
Group 2 - Mild Renal Impairment	VNRX-7145	Mild Renal Impairment
Group 3 - Moderate Renal Impairment	VNRX-7145	Moderate Renal Impairment
Group 5 - End Stage Renal Disease	VNRX-7145	End Stage Renal Disease undergoing chronic intermittent hemodialysis
Group 3 - Moderate Renal Impairment	Ceftibuten	Moderate Renal Impairment
Group 5 - End Stage Renal Disease	Ceftibuten	End Stage Renal Disease undergoing chronic intermittent hemodialysis

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Nucleus Network; 🇺🇸 Saint Paul, Minnesota, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Advanced Pharma; 🇺🇸 Miami, Florida, United States