Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants

NCT05527834 | Completed Phase 1 FDA Drug

• 2 other identifiers: VNRX-7145-104272201600029C-P00017-9999-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Cmax

  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

  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

  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

Study Arms (3)

Cohort 1

EXPERIMENTAL

Cohort 1 will assess the impact of a high fat meal.

Drug: VNRX-7145; Drug: Ceftibuten

Cohort 2

EXPERIMENTAL

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; Drug: Ceftibuten

Cohort 3

EXPERIMENTAL

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; Drug: Ceftibuten

Interventions

Ceftibuten DRUG

Single oral dose

Cohort 1; Cohort 2; Cohort 3

VNRX-7145 DRUG

Single oral dose

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Basilea Pharmaceutica: lead

Study Sites (1)

ICON Plc.

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Interventions

Ceftibuten

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kamal Hamed, MD

  Basilea Pharmaceutica International Ltd, Allschwil

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: September 13, 2022
• Primary Completion: February 6, 2023
• Study Completion: February 10, 2023
• Last Updated: December 8, 2025

Record last verified: 2025-11

Locations

US (1)