VNRX-5133 With VNRX-5022 in Subjects With Varying Degrees of Renal Impairment

NCT ID: NCT03690362

Last Updated: 2019-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-06
• Study Completion Date: 2018-11-21

Brief Summary

This is a multi-center, open-label, PK and safety study of VNRX-5133 and VNRX-5022 when co-administered in male and female subjects with varying levels of renal impairment and healthy normal controls.

Conditions

Pharmacokinetics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Group 1 - Control

Healthy control subjects will be matched by gender, weight, and age to subjects with renal impairment

Group Type: EXPERIMENTAL

VNRX-5133 and VNRX-5022

Intervention Type: DRUG

intravenous infusion

Group 2 - Mild Renal Impairment

Mild renal impairment

Group Type: EXPERIMENTAL

VNRX-5133 and VNRX-5022

Intervention Type: DRUG

intravenous infusion

Group 3 - Moderate Renal Impairment

Moderate Renal Impairment

Group Type: EXPERIMENTAL

VNRX-5133 and VNRX-5022

Intervention Type: DRUG

intravenous infusion

Group 4 - Severe Renal Impairment

Severe Renal Impairment

Group Type: EXPERIMENTAL

VNRX-5133 and VNRX-5022

Intervention Type: DRUG

intravenous infusion

Group 5 - ESRD

End Stage Renal Disease undergoing chronic intermittent hemodialysis

Group Type: EXPERIMENTAL

VNRX-5133 and VNRX-5022

Intervention Type: DRUG

intravenous infusion

Interventions

VNRX-5133 and VNRX-5022

intravenous infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• BMI: 18.5-40.0 kg/m2 with a minimum weight of 45 kg
• Able and willing to abstain from alcohol from 48 h before admission until the follow-up visit
• Suitable veins for cannulation/multiple venipunctures, as assessed by the Investigator at Screening
• Males who are not surgically sterilized and females of childbearing potential must agree to use highly effective methods of contraception during the study and for 90 days after study drug administration.
• Laboratory values meeting defined entry criteria

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

• Match to one or more subjects with renal impairment by gender, age, and weight

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

• Stable, pre-existing renal impairment.

Exclusion Criteria

• Employee of the study site, Contract Research Organization (CRO) or the IND Sponsor
• Female who is pregnant, lactating, or planning to attempt to become pregnant during the study or within 90 days after study drug administration
• Male with a female partner who is pregnant or lactating during the study, or planning to attempt to become pregnant during the study or within 90 days after study drug administration
• Use of any investigational drug or device within 30 days before study drug administration (90 days for an injectable biological agent)
• The subject has a congenital or acquired immunodeficiency syndrome
• Screening or Day -1, clinically significant abnormal ECG values
• Active malignancy; exceptions are permitted for carcinoma in situ of the prostate or the skin (basal cell or squamous cell) are permitted
• History of drug allergy of a severity that required urgent medical treatment, such as treatment with epinephrine in an Emergency Department
• Known immediate hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug
• History of donation of more than 450 mL of blood within 60 days before dosing in the site or planned donation before 30 days has elapsed since ingestion of study drug
• Plasma or platelet donation within 7 days of dosing and throughout the study
• Consumes more than 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of hard liquor) or has a significant history of alcohol abuse or drug/chemical abuse within the last 1 year
• Oral temperature >38.5˚C or acute illness on Day -1
• Previous participation in a study of VNRX-5133
• Excluded concomitant medication

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Venatorx Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Orlando Cliniical Research Associates

Orlando, Florida, United States

New Orleans Center for Clinical Research

Knoxville, Tennessee, United States

Countries

United States

References

Dowell JA, Marbury TC, Smith WB, Henkel T. Safety and Pharmacokinetics of Taniborbactam (VNRX-5133) with Cefepime in Subjects with Various Degrees of Renal Impairment. Antimicrob Agents Chemother. 2022 Sep 20;66(9):e0025322. doi: 10.1128/aac.00253-22. Epub 2022 Aug 3.

Reference Type: DERIVED

PMID: 35920662 (View on PubMed)

Other Identifiers

272201300019C-12-0-3

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-0103

Identifier Type: OTHER

Identifier Source: secondary_id

VNRX-5133-104

Identifier Type: -

Identifier Source: org_study_id