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VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers

NCT03332732 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-10-18

No results posted yet for this study

Summary

This is a 2-part, drug-drug interaction study to evaluate potential PK interactions after single doses in Part 1 and multiple doses in Part 2. In Part 1, subjects will receive single dose of 5 treatments in a cross-over design; in Part 2 subjects will receive treatment for 10 days.

Conditions

Interventions

DRUG

VNRX-5133

β-lactamase inhibitor

DRUG

VNRX-5022

Approved β-lactam antibiotic

DRUG

Metronidazole

Approved antibiotic and antiprotozoal medication

DRUG

Placebo

Placebo (matching VNRX-5133 + VNRX-5022)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Venatorx Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-24
Primary Completion
2017-12-20
Completion
2017-12-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03332732 on ClinicalTrials.gov