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

VNRX-7145-103

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.

2022-10-12

2023-11-21

2023-11-21

Completed

Early phase I

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will enroll approximately 32 participants assigned to groups based on renal function.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}

2023-12-22