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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04877379

Enrollment

Registered

2021-05-07

Start date

2021-06-08

Completion date

2021-11-10

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief summary

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.

Interventions

DRUGVNRX-7145

β-lactamase inhibitor

DRUGVNRX-5024 (ceftibuten)

β-lactam antibiotic

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Masking description

Part 1: Unblinded Parts 2&3: Blinded

Intervention model description

Part 1: Crossover Parts 2&3: Parallel

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026