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

Sponsor

Venatorx Pharmaceuticals, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05488678

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Enrollment

Locations

Arms

Anticipated Duration (Months)

10.7

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pharmacokinetics	Drug: VNRX-7145 Drug: Ceftibuten	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study will enroll approximately 32 participants assigned to groups based on renal function.The study will enroll approximately 32 participants assigned to groups based on renal function.

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 - Control Healthy control participants will be matched by gender, age, and BMI to participants with renal impairment	Drug: VNRX-7145 single oral dose Drug: Ceftibuten single oral dose
Experimental: Group 2 - Mild Renal Impairment Mild Renal Impairment	Drug: VNRX-7145 single oral dose Drug: Ceftibuten single oral dose
Experimental: Group 3 - Moderate Renal Impairment Moderate Renal Impairment	Drug: VNRX-7145 single oral dose Drug: Ceftibuten single oral dose
Experimental: Group 4 - Severe Renal Impairment Severe Renal Impairment	Drug: VNRX-7145 single oral dose Drug: Ceftibuten single oral dose
Experimental: Group 5 - End Stage Renal Disease End Stage Renal Disease undergoing chronic intermittent hemodialysis	Drug: VNRX-7145 single oral dose Drug: Ceftibuten single oral dose

Outcome Measures

Primary Outcome Measures

Cmax [0-120 hours post dose]
Maximum plasma concentration, determined directly from individual concentration time data
AUC0-inf [0-120 hours post dose]
Area under the plasma concentration time curve from time zero extrapolated to infinity based on collected PK
Number of subjects with adverse events [8 days post dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 82 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Pharma	Miami	Florida	United States	33147
2	Orlando Clinical Research Center	Orlando	Florida	United States	32809
3	Nucleus Network	Saint Paul	Minnesota	United States	55114

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Venatorx Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT05488678

Other Study ID Numbers:

VNRX-7145-103
272201600029C-P00017-9999-1
21-0032

First Posted:

Aug 4, 2022

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ceftibuten

Study Results

No Results Posted as of Aug 4, 2022