VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers

VNRX-5133-103: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics of VNRX-5133 in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03332732

Enrollment

Registered

2017-11-06

Start date

2017-10-24

Completion date

2017-12-20

Last updated

2018-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections

Keywords

Healthy Volunteers, Pharmacokinetics

Brief 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.

Interventions

DRUGVNRX-5133

β-lactamase inhibitor

DRUGVNRX-5022

Approved β-lactam antibiotic

DRUGMetronidazole

Approved antibiotic and antiprotozoal medication

DRUGPlacebo

Placebo (matching VNRX-5133 + VNRX-5022)

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Part 1: Cross-over Part 2: Parallel

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy adults * Males or non-pregnant, non-lactating females * Body Mass Index (BMI) between 18.5 - 32.0, inclusive * Weight greater than or equal to 50 kg * Suitable veins for cannulation

Exclusion criteria

* Employee of site or the sponsor * Any disease that poses an unacceptable risk to participants * Abnormal ECG * Abnormal labs * Abnormal vital signs * Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder * Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1

Design outcomes

Primary

Measure	Time frame	Description
Area under the plasma concentration versus time curve (AUC) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)	0-48 hours	AUCinf
Peak Plasma Concentration (Cmax) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)	0-48 hours	Cmax

Secondary

Measure	Time frame	Description
Area under the plasma concentration versus time curve (AUC) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)	0-48 hours	AUCinf
Accumulation of VNRX-5133 + VNRX-5022 following multiple dose administration	Part 2: 10 days	Trough concentration levels from Day 1 - Day 10
Number of Subjects with Treatment Emergent Adverse Events	First dose to 7 days after last dose: Part 1: 20 days / Part 2: 17 days	TEAEs based on patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.
Peak Plasma Concentration (Cmax) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)	0-48 hours	Cmax

Other

Measure	Time frame	Description
Bactericidal titers (Part 2)	10 days	To evaluate serum and urine bactericidal activity at peak and trough concentrations following multiple dose administration of VNRX-5133 + VNRX-5022

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026