Safety and Pharmacokinetics of VNRX-5133 in the Epithelial Lining Fluid of Healthy Adult Subjects
NCT03870490 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2019-05-06
Summary
This is a single-center, open-label study to assess safety and pharmacokinetics of VNRX-5133 and cefepime in the epithelial lining fluid in healthy adult male and female subjects.
Conditions
- Healthy Subjects
Interventions
- DRUG
-
VNRX-5133 + cefepime
IV infusion (3 doses)
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
Venatorx Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-03-14
- Primary Completion
- 2019-04-01
- Completion
- 2019-04-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects
NCT05368935 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of XNW4107 in Subjects With Various Degrees of Renal Function
NCT04787562 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety, Tolerability and Pharmacokinetic Study of a Single Dose of CMX157 in Healthy Volunteers
NCT01080820 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, and Pharmacokinetics of Modified and Immediate Release Anatabine Citrate Formulations
NCT02432313 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess the Pharmacokinetics and Safety of AZD9977 in Participants With Renal Impairment
NCT04469907 ·Status: COMPLETED ·Phase: PHASE1
-
A Two-part Pharmacokinetic Study of PXS-5382A in Healthy Adult Males
NCT04183517 ·Status: COMPLETED ·Phase: PHASE1
-
A Study To Investigate The Pharmacokinetics, Safety And Tolerability Of An Intravenous And Oral Form Of A Compound In Subjects With Varying Degrees Of Renal Impairment And Normal Renal Function
NCT00759564 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics of MP-3180 and Use of Noninvasive Fluorescence Detection Device in Healthy Volunteers
NCT02098187 ·Status: COMPLETED ·Phase: PHASE1
-
Hepatic Impairment and Renal Impairment Study of SIM0417 Combined With Ritonavir
NCT05731804 ·Status: UNKNOWN ·Phase: PHASE1
-
Pharmacokinetic Parameters of Stiripentol in Renal Impaired Patients and Matching Controls With Normal Renal Function
NCT05735951 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
NCT06539507 ·Status: RECRUITING ·Phase: PHASE1
-
Study of Pharmacokinetics of a Single IV Dose of CB-238,618 in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Subjects (MK-6183-001)
NCT02341599 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Renal Function
NCT04476849 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects
NCT02770404 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Estimate the Effect of CYP3A4 Inhibitors (Itraconazole, Diltiazem or Verapamil) on the Pharmacokinetics of Single Dose PF- 00489791 in Healthy Volunteers
NCT02319148 ·Status: COMPLETED ·Phase: PHASE1
-
To Assess the Effect of AZD1722 on the Pharmacokinetics of Cefadroxil in Healthy Volunteers
NCT02140281 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Pharmacokinetics Study of Redosing EXPAREL in Healthy Volunteers
NCT02210247 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment
NCT07104162 ·Status: RECRUITING ·Phase: PHASE1
-
Study in Healthy Adult Subjects to Assess the Effect of Phosphate Binders on the Pharmacokinetics of a Single Dose of Vadadustat
NCT04299633 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess the Metabolism and Elimination of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects
NCT01359605 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of the Pharmacokinetics and Safety of VX-548 in Participants With Mild or Moderate Hepatic Impairment
NCT05560464 ·Status: COMPLETED ·Phase: PHASE1
-
Study in Healthy Volunteers to Investigate the Effects of Rifampin on the Pharmacokinetics of NKTR-118
NCT01533870 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Study on G1090N (Nitazoxanide) Capsules in Healthy Volunteers
NCT07110441 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics and Safety of ABT-493 and ABT-530 in Subjects With Normal and Impaired Renal Function
NCT02442258 ·Status: COMPLETED ·Phase: PHASE1
-
PK and PD Study of IDN-6556 in Subjects With Severe Renal Impairment and Matched Healthy Volunteers
NCT02039817 ·Status: COMPLETED ·Phase: PHASE1