VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers

VNRX-7145-102: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics (PK) of VNRX-7145 and VNRX-5024 (Ceftibuten) in Healthy Adult Volunteers

This study will provide an initial assessment of the safety and PK of VNRX-7145 and VNRX-5024 (ceftibuten) when administered as single agents and with co-administration in a single dose cross-over design in Part 1. In Part 2, subjects will receive 500 mg of VNRX-7145 or matching placebo q8h for 10 days. VNRX-7145 and VNRX-5024 (ceftibuten) will be administered every 8 hours (q8h) for 10 days at 2 dose levels of VNRX-7145 in Part 3.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Placebo; Drug: VNRX-7145; Drug: VNRX-5024 (ceftibuten)

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • PRA Health Sciences - Early Development Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy adults 18-55 years
2. Males or non-pregnant, non-lactating females
3. Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
4. Normal blood pressure
5. Normal lab tests

Exclusion Criteria:

1. History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders
2. History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
3. Use of antacid medications
4. Abnormal ECG or history of clinically significant abnormal rhythm disorder
5. Positive alcohol, drug, or tobacco use/test

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1; Subjects will receive single doses of VNRX-7145 or VNRX-5024 alone and in combination. All subjects will receive study drug in the sequence specified by the randomization schedule.	Drug: VNRX-7145; β-lactamase inhibitor; Drug: VNRX-5024 (ceftibuten); β-lactam antibiotic
Experimental: Part 2A; Multiple dose administration of VNRX-7145 q8h for 10 days	Drug: VNRX-7145; β-lactamase inhibitor
Placebo Comparator: Part 2B; Multiple dose administration of placebo q8h for 10 days	Drug: Placebo; Placebo
Experimental: Part 3A; Multiple dose administration of low dose VNRX-7145 + VNRX-5024	Drug: VNRX-7145; β-lactamase inhibitor; Drug: VNRX-5024 (ceftibuten); β-lactam antibiotic
Experimental: Part 3B; Multiple dose administration of high dose VNRX-7145 + VNRX-5024	Drug: VNRX-7145; β-lactamase inhibitor; Drug: VNRX-5024 (ceftibuten); β-lactam antibiotic
Placebo Comparator: Part 3C; Multiple dose administration of Placebo (matching VNRX-7145 + VNRX-5024)	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Cmax	concentration time data	0-48 hours
Part 1: AUC0-inf	Area under the concentration-time curve from time-zero extrapolated to infinity based on collected PK	0-48 hours
Parts 2&3: Number of subjects with adverse events		Day 15 (+2)

Secondary Outcome Measures

Outcome Measure	Time Frame
Part 1: Number of subjects with adverse events	Day 14 (+2)
Parts 2&3: AUC0-tau	Day 1
Parts 2&3: AUC0-tau	Day 10
Parts 2&3: Cmax	Day 1
Parts 2&3: Cmax	Day 10

Collaborators and Investigators

• Sponsor: Basilea Pharmaceutica
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Director: Kamal Hamed, MD, Basilea Pharmaceutica International Ltd, Allschwil

Publications and helpful links

General Publications

• de Oliveira CF, Dorr MB, van de Wetering J, Lowe K, Sabato P, Winchell G, Chen H, McGovern PC. Safety and pharmacokinetics of single and multiple doses of ledaborbactam etzadroxil with or without ceftibuten in healthy volunteers. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0021025. doi: 10.1128/aac.00210-25. Epub 2025 Aug 5.

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Actual): November 10, 2021
• Study Completion (Actual): November 10, 2021

Study Registration Dates

• First Submitted: May 3, 2021
• First Submitted That Met QC Criteria: May 3, 2021
• First Posted (Actual): May 7, 2021

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: Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amides; beta-Lactams; Lactams; Cephalosporins; Thiazines; Ceftibuten
• Other Study ID Numbers: VNRX-7145-102; 272201600029C-P00007-9999-2 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No