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

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05488678
• Other study ID #: VNRX-7145-103
• Secondary ID: 272201600029C-P0
• Status: Completed
• Phase: Phase 1
• Start date: October 12, 2022
• Est. completion date: November 21, 2023

Study information

• Verified date: December 2023
• Source: Venatorx Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 21, 2023
• Est. primary completion date: November 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 82 Years

Eligibility

Inclusion Criteria:

• Healthy adults 18-82 years

• Males or non-pregnant, non-lactating females

• Body mass index (BMI): =18.5 kg/m2 and =40.0 kg/m2

• Laboratory values meeting defined entry criteria

Subjects with normal renal function (Group 1) must also meet the following criteria:

• Match to one or more participants with renal impairment by gender, age, and BMI

Subjects with renal impairment (Groups 2-5) must also meet the following criteria:

• Stable, pre-existing renal impairment

Exclusion Criteria:

• History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug

• Congenital or acquired immunodeficiency syndrome

• Major adverse cardiovascular event within one year of dosing

• Positive alcohol, drug, or tobacco use/test

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• VNRX-7145
single oral dose
• Ceftibuten
single oral dose

Locations

Country	Name	City	State
United States	Advanced Pharma	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Nucleus Network	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Venatorx Pharmaceuticals, Inc.	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum plasma concentration, determined directly from individual concentration time data	0-120 hours post dose
Primary	AUC0-inf	Area under the plasma concentration time curve from time zero extrapolated to infinity based on collected PK	0-120 hours post dose
Primary	Number of subjects with adverse events		8 days post dose