VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers

Sponsor

Venatorx Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03332732

Collaborator

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Enrollment

Location

Arms

1.9

Actual Duration (Months)

22.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bacterial Infections	Drug: VNRX-5133 Drug: VNRX-5022 Drug: Metronidazole Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Part 1: Cross-over Part 2: ParallelPart 1: Cross-over Part 2: Parallel

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Oct 24, 2017

Actual Primary Completion Date :

Dec 20, 2017

Actual Study Completion Date :

Dec 20, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1A 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-5133 β-lactamase inhibitor Drug: VNRX-5022 Approved β-lactam antibiotic
Experimental: Part 1B 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-5133 β-lactamase inhibitor Drug: VNRX-5022 Approved β-lactam antibiotic Drug: Metronidazole Approved antibiotic and antiprotozoal medication
Experimental: Part 2 - 2A Multiple dose administration of Low Dose VNRX-5133 + VNRX-5022	Drug: VNRX-5133 β-lactamase inhibitor Drug: VNRX-5022 Approved β-lactam antibiotic
Experimental: Part 2 - 2B Multiple dose administration of High Dose VNRX-5133 + VNRX-5022	Drug: VNRX-5133 β-lactamase inhibitor Drug: VNRX-5022 Approved β-lactam antibiotic
Placebo Comparator: Part 2 - 2C Multiple dose administration of Placebo (matching VNRX-5133 + VNRX-5022)	Drug: Placebo Placebo (matching VNRX-5133 + VNRX-5022)

Outcome Measures

Primary Outcome Measures

Peak Plasma Concentration (Cmax) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A) [0-48 hours]
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) [0-48 hours]
AUCinf

Secondary Outcome Measures

Peak Plasma Concentration (Cmax) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B) [0-48 hours]
Cmax
Area under the plasma concentration versus time curve (AUC) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B) [0-48 hours]
AUCinf
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.
Accumulation of VNRX-5133 + VNRX-5022 following multiple dose administration [Part 2: 10 days]
Trough concentration levels from Day 1 - Day 10

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRAHS	Lenexa	Kansas	United States	66219

Sponsors and Collaborators

Venatorx Pharmaceuticals, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Venatorx Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT03332732

Other Study ID Numbers:

VNRX-5133-103
272201300019C-3-0-1
17-0068

First Posted:

Nov 6, 2017

Last Update Posted:

Oct 18, 2018

Last Verified:

Oct 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Venatorx Pharmaceuticals, Inc.

Healthy Volunteers

Pharmacokinetics

Additional relevant MeSH terms:

Bacterial Infections

Metronidazole

Study Results

No Results Posted as of Oct 18, 2018