NCT04877379

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	VNRX-7145	β-lactamase inhibitor
DRUG	VNRX-5024 (ceftibuten)	β-lactam antibiotic
DRUG	Placebo	Placebo

Timeline

• Start date: 2021-06-08
• Primary completion: 2021-11-10
• Completion: 2021-11-10
• First posted: 2021-05-07
• Last updated: 2025-12-08

Locations

1 site across 1 country: Netherlands