NCT03332732

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

October 24, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

2 months

First QC Date

September 28, 2017

Last Update Submit

October 17, 2018

Conditions

Bacterial Infections

Keywords

Healthy VolunteersPharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Peak Plasma Concentration (Cmax) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)

    Cmax

    0-48 hours

  • Area under the plasma concentration versus time curve (AUC) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)

    AUCinf

    0-48 hours

Secondary Outcomes (4)

  • Peak Plasma Concentration (Cmax) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)

    0-48 hours

  • Area under the plasma concentration versus time curve (AUC) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)

    0-48 hours

  • Number of Subjects with Treatment Emergent Adverse Events

    First dose to 7 days after last dose: Part 1: 20 days / Part 2: 17 days

  • Accumulation of VNRX-5133 + VNRX-5022 following multiple dose administration

    Part 2: 10 days

Other Outcomes (1)

  • Bactericidal titers (Part 2)

    10 days

Study Arms (5)

Part 1A

EXPERIMENTAL

In Part 1A, subjects will receive single doses of VNRX-5133 and VNRX-5022 alone and in combination. All subjects will receive all treatments in the sequence specified by the randomization schedule..

Drug: VNRX-5133Drug: VNRX-5022

Part 1B

EXPERIMENTAL

In part 1B, subjects from Part 1A will receive metronidazole with or without VNRX-5133 + VNRX-5022. All subjects will receive all treatments in the sequence specified by the randomization schedule.

Drug: VNRX-5133Drug: VNRX-5022Drug: Metronidazole

Part 2 - 2A

EXPERIMENTAL

Multiple dose administration of Low Dose VNRX-5133 + VNRX-5022

Drug: VNRX-5133Drug: VNRX-5022

Part 2 - 2B

EXPERIMENTAL

Multiple dose administration of High Dose VNRX-5133 + VNRX-5022

Drug: VNRX-5133Drug: VNRX-5022

Part 2 - 2C

PLACEBO COMPARATOR

Multiple dose administration of Placebo (matching VNRX-5133 + VNRX-5022)

Drug: Placebo

Interventions

VNRX-5133DRUG

β-lactamase inhibitor

Part 1APart 1BPart 2 - 2APart 2 - 2B
VNRX-5022DRUG

Approved β-lactam antibiotic

Part 1APart 1BPart 2 - 2APart 2 - 2B
MetronidazoleDRUG

Approved antibiotic and antiprotozoal medication

Part 1B
PlaceboDRUG

Placebo (matching VNRX-5133 + VNRX-5022)

Part 2 - 2C

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRAHS

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

taniborbactamMetronidazole

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Model Details: Part 1: Cross-over Part 2: Parallel
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2017

First Posted

November 6, 2017

Study Start

October 24, 2017

Primary Completion

December 20, 2017

Study Completion

December 20, 2017

Last Updated

October 18, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)