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

Pharmacokinetics Clinical Trial

Official title:

A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VNRX-5133 With VNRX-5022 in Subjects With Varying Degrees of Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03690362
• Other study ID #: VNRX-5133-104
• Secondary ID: 272201300019C-12
• Status: Completed
• Phase: Phase 1
• Start date: April 6, 2018
• Est. completion date: November 21, 2018

Study information

• Verified date: February 2019
• Source: VenatoRx Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 21, 2018
• Est. primary completion date: November 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Pharmacokinetics
• Renal Insufficiency

Intervention

Drug:
• VNRX-5133 and VNRX-5022
intravenous infusion

Locations

Country	Name	City	State
United States	New Orleans Center for Clinical Research	Knoxville	Tennessee
United States	Orlando Cliniical Research Associates	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
VenatoRx Pharmaceuticals, Inc.	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)	To assess the pharmacokinetics of VNRX-5133 and VNRX-5022 in combination by assessment of Cmax	72 hours
Primary	Area under the plasma concentration versus time curve (AUC)	To assess the pharmacokinetics of VNRX-5133 and VNRX-5022 in combination by assessment of AUC	72 hours
Primary	Safety and tolerability of VNRX-5133 and VNRX-5022 measured as number of subjects with adverse events.	Number of Subjects with AEs (Assessed via patient report, physical exam, ECGs, vital signs, laboratory investigations, and use of concomitant medications for the treatment of AEs)	8 Days