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

Venatorx Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: VNRX-5133 and VNRX-5022

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT03690362

272201300019C-12-0-3 (U.S. NIH Grant/Contract)

17-0103 (Other Identifier)

VNRX-5133-104

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 5 patient groups

Group 1 - Control

Experimental group

Description:

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

Treatment:

Drug: VNRX-5133 and VNRX-5022

Group 2 - Mild Renal Impairment

Experimental group

Description:

Mild renal impairment

Treatment:

Drug: VNRX-5133 and VNRX-5022

Group 3 - Moderate Renal Impairment

Experimental group

Description:

Moderate Renal Impairment

Treatment:

Drug: VNRX-5133 and VNRX-5022

Group 4 - Severe Renal Impairment

Experimental group

Description:

Severe Renal Impairment

Treatment:

Drug: VNRX-5133 and VNRX-5022

Group 5 - ESRD

Experimental group

Description:

End Stage Renal Disease undergoing chronic intermittent hemodialysis

Treatment:

Drug: VNRX-5133 and VNRX-5022