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VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers

Primary Purpose

Bacterial Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VNRX-5133
VNRX-5022
Metronidazole
Placebo
Sponsored by
Venatorx Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bacterial Infections focused on measuring Healthy Volunteers, Pharmacokinetics

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • PRAHS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Part 1A

Part 1B

Part 2 - 2A

Part 2 - 2B

Part 2 - 2C

Arm Description

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..

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.

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Peak Plasma Concentration (Cmax) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)
Cmax
Area under the plasma concentration versus time curve (AUC) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)
AUCinf
Number of Subjects with Treatment Emergent Adverse Events
TEAEs based on patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.
Accumulation of VNRX-5133 + VNRX-5022 following multiple dose administration
Trough concentration levels from Day 1 - Day 10

Full Information

First Posted
September 28, 2017
Last Updated
October 17, 2018
Sponsor
Venatorx Pharmaceuticals, Inc.
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT03332732
Brief Title
VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers
Official Title
VNRX-5133-103: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics of VNRX-5133 in Healthy Adult Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
December 20, 2017 (Actual)
Study Completion Date
December 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venatorx Pharmaceuticals, Inc.
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections
Keywords
Healthy Volunteers, Pharmacokinetics

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Part 1: Cross-over Part 2: Parallel
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1A
Arm Type
Experimental
Arm Description
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..
Arm Title
Part 1B
Arm Type
Experimental
Arm Description
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.
Arm Title
Part 2 - 2A
Arm Type
Experimental
Arm Description
Multiple dose administration of Low Dose VNRX-5133 + VNRX-5022
Arm Title
Part 2 - 2B
Arm Type
Experimental
Arm Description
Multiple dose administration of High Dose VNRX-5133 + VNRX-5022
Arm Title
Part 2 - 2C
Arm Type
Placebo Comparator
Arm Description
Multiple dose administration of Placebo (matching VNRX-5133 + VNRX-5022)
Intervention Type
Drug
Intervention Name(s)
VNRX-5133
Intervention Description
β-lactamase inhibitor
Intervention Type
Drug
Intervention Name(s)
VNRX-5022
Intervention Description
Approved β-lactam antibiotic
Intervention Type
Drug
Intervention Name(s)
Metronidazole
Intervention Description
Approved antibiotic and antiprotozoal medication
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (matching VNRX-5133 + VNRX-5022)
Primary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)
Description
Cmax
Time Frame
0-48 hours
Title
Area under the plasma concentration versus time curve (AUC) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)
Description
AUCinf
Time Frame
0-48 hours
Secondary Outcome Measure Information:
Title
Peak Plasma Concentration (Cmax) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)
Description
Cmax
Time Frame
0-48 hours
Title
Area under the plasma concentration versus time curve (AUC) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)
Description
AUCinf
Time Frame
0-48 hours
Title
Number of Subjects with Treatment Emergent Adverse Events
Description
TEAEs based on patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.
Time Frame
First dose to 7 days after last dose: Part 1: 20 days / Part 2: 17 days
Title
Accumulation of VNRX-5133 + VNRX-5022 following multiple dose administration
Description
Trough concentration levels from Day 1 - Day 10
Time Frame
Part 2: 10 days
Other Pre-specified Outcome Measures:
Title
Bactericidal titers (Part 2)
Description
To evaluate serum and urine bactericidal activity at peak and trough concentrations following multiple dose administration of VNRX-5133 + VNRX-5022
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
PRAHS
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers

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