NCT05488678

Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function

VNRX-7145-103: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years – 82 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, multicenter, parallel-group study in participants with normal renal function, mild, moderate, or severe renal impairment, or end stage renal disease (ESRD) undergoing standard intermittent dialysis. 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

Interventions

Type	Name	Description
DRUG	VNRX-7145	single oral dose
DRUG	Ceftibuten	single oral dose

Timeline

• Start date: 2022-10-12
• Primary completion: 2023-11-23
• Completion: 2023-11-23
• First posted: 2022-08-04
• Last updated: 2025-12-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study