Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants

Completed · Phase 1

Conditions studied: Pharmacokinetics

In brief

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.

Key facts

Study ID

NCT05527834

Run by

Basilea Pharmaceutica

People needed

24

Starts

2022-09-13

Expected to finish

2023-02-10

Last updated by the study team

2025-12-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ICON Plc. — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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