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

Basilea Pharmaceutica

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Ceftibuten; Drug: VNRX-7145

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT05488678

272201600029C-P00026-9999-1 (U.S. NIH Grant/Contract)

VNRX-7145-103

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 82 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 5 patient groups

Group 1 - Control

Experimental group

Description:

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

Treatment:

Drug: VNRX-7145

Drug: Ceftibuten

Group 2 - Mild Renal Impairment

Experimental group

Description:

Mild Renal Impairment

Treatment:

Drug: VNRX-7145

Drug: Ceftibuten

Group 3 - Moderate Renal Impairment

Experimental group

Description:

Moderate Renal Impairment

Treatment:

Drug: VNRX-7145

Drug: Ceftibuten

Group 4 - Severe Renal Impairment

Experimental group

Description:

Severe Renal Impairment

Treatment:

Drug: VNRX-7145

Drug: Ceftibuten

Group 5 - End Stage Renal Disease

Experimental group

Description:

End Stage Renal Disease undergoing chronic intermittent hemodialysis

Treatment:

Drug: VNRX-7145

Drug: Ceftibuten