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

NCT05488678 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-12-08

No results posted yet for this study

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

DRUG

VNRX-7145

single oral dose

DRUG

Ceftibuten

single oral dose

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
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-10-12
Primary Completion
2023-11-23
Completion
2023-11-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05488678 on ClinicalTrials.gov