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Completed

NCT Number: NCT05527834

Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants

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.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Plc.

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VNRX-7145

Drug

Single oral dose

Ceftibuten

Drug

Single oral dose

Primary outcomes

  1. Cmax

    Time frame: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects

    Maximum observed plasma concentration (Cmax)

  2. AUC0-t

    Time frame: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects

    Area under the plasma concentration-time curve (AUC) from time 0 up to the last quantifiable concentration at time t (AUC0-t)

  3. AUC0-inf

    Time frame: 0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects

    AUC from time 0 extrapolated to infinity (AUC0-inf)

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2022
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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