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

NCT ID: NCT05488678

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-12

Study Completion Date

2023-11-23

Brief Summary

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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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Detailed Description

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Conditions

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Pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1 - Control

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

Group Type EXPERIMENTAL

VNRX-7145

Intervention Type DRUG

single oral dose

Ceftibuten

Intervention Type DRUG

single oral dose

Group 2 - Mild Renal Impairment

Mild Renal Impairment

Group Type EXPERIMENTAL

VNRX-7145

Intervention Type DRUG

single oral dose

Ceftibuten

Intervention Type DRUG

single oral dose

Group 3 - Moderate Renal Impairment

Moderate Renal Impairment

Group Type EXPERIMENTAL

VNRX-7145

Intervention Type DRUG

single oral dose

Ceftibuten

Intervention Type DRUG

single oral dose

Group 4 - Severe Renal Impairment

Severe Renal Impairment

Group Type EXPERIMENTAL

VNRX-7145

Intervention Type DRUG

single oral dose

Ceftibuten

Intervention Type DRUG

single oral dose

Group 5 - End Stage Renal Disease

End Stage Renal Disease undergoing chronic intermittent hemodialysis

Group Type EXPERIMENTAL

VNRX-7145

Intervention Type DRUG

single oral dose

Ceftibuten

Intervention Type DRUG

single oral dose

Interventions

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VNRX-7145

single oral dose

Intervention Type DRUG

Ceftibuten

single oral dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

Basilea Pharmaceutica

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kamal Hamed, MD

Role: STUDY_DIRECTOR

Basilea Pharmaceutica International Ltd, Allschwil

Locations

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Advanced Pharma

Miami, Florida, United States

Site Status

Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

Nucleus Network

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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272201600029C-P00026-9999-1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VNRX-7145-103

Identifier Type: -

Identifier Source: org_study_id

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