VNRX-5133 With VNRX-5022 in Subjects With Varying Degrees of Renal Impairment
Phase 1
Completed
- Conditions
- Pharmacokinetics
- Interventions
- Drug: VNRX-5133 and VNRX-5022
- Registration Number
- NCT03690362
- Lead Sponsor
- Venatorx Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group 1 - Control VNRX-5133 and VNRX-5022 Healthy control subjects will be matched by gender, weight, and age to subjects with renal impairment Group 2 - Mild Renal Impairment VNRX-5133 and VNRX-5022 Mild renal impairment Group 5 - ESRD VNRX-5133 and VNRX-5022 End Stage Renal Disease undergoing chronic intermittent hemodialysis Group 3 - Moderate Renal Impairment VNRX-5133 and VNRX-5022 Moderate Renal Impairment Group 4 - Severe Renal Impairment VNRX-5133 and VNRX-5022 Severe Renal Impairment
- Primary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) 72 hours To assess the pharmacokinetics of VNRX-5133 and VNRX-5022 in combination by assessment of Cmax
Area under the plasma concentration versus time curve (AUC) 72 hours To assess the pharmacokinetics of VNRX-5133 and VNRX-5022 in combination by assessment of AUC
Safety and tolerability of VNRX-5133 and VNRX-5022 measured as number of subjects with adverse events. 8 Days 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
New Orleans Center for Clinical Research
🇺🇸Knoxville, Tennessee, United States
Orlando Cliniical Research Associates
🇺🇸Orlando, Florida, United States