VNRX-7145-104: an Open-label, Cross-over Study to Evaluate the Effect of Food on the Pharmacokinetics, Safety, and Tolerability of Ceftibuten/VNRX-7145 in Healthy Participants.

VNRX-7145-104

This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). 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.

2022-09-13

2023-02-06

2023-02-10

Completed

Early phase I

24

Inclusion Criteria: * Healthy adults 18-65 years * Males or non-pregnant, non-lactating females * Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2 * Laboratory values meeting defined entry criteria Exclusion Criteria: * History of drug allergy or hypersensitivity to penicillin, cephalosporin, or β-lactam antibacterial drug * Conditions that potentially alter absorption and/or excretion of orally administered drugs * Congenital or acquired immunodeficiency syndrome * Positive alcohol, drug, or tobacco use/test

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}

2023-07-18