Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants

December 1, 2025 updated by: Basilea Pharmaceutica

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • ICON plc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Cohort 1 will assess the impact of a high fat meal.
Drug: VNRX-7145
Single oral dose
Drug: Ceftibuten
Single oral dose
Experimental: Cohort 2
Cohort 2 will be conducted to assess the impact of an alternative lower fat meal if administration with high fat meal has a food effect on drug exposure.
Drug: VNRX-7145
Single oral dose
Drug: Ceftibuten
Single oral dose
Experimental: Cohort 3
Cohort 3 will evaluate realistic fasting intervals and/or additional meal types if administration with food has a food effect on drug exposure.
Drug: VNRX-7145
Single oral dose
Drug: Ceftibuten
Single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
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)
0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects
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)
0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basilea Pharmaceutica

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Director: Kamal Hamed, MD, Basilea Pharmaceutica International Ltd, Allschwil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2022

Primary Completion (Actual)

February 6, 2023

Study Completion (Actual)

February 10, 2023

Study Registration Dates

First Submitted

September 1, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VNRX-7145-104
  • 272201600029C-P00017-9999-1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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