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VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers

NCT04877379 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-12-08

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

DRUG

VNRX-7145

β-lactamase inhibitor

DRUG

VNRX-5024 (ceftibuten)

β-lactam antibiotic

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Basilea Pharmaceutica

    lead INDUSTRY

Principal Investigators

  • Kamal Hamed, MD · Basilea Pharmaceutica International Ltd, Allschwil

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-08
Primary Completion
2021-11-10
Completion
2021-11-10

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04877379 on ClinicalTrials.gov