VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-24

Study Completion Date

2017-12-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Bacterial Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Part 1: Cross-over Part 2: Parallel

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Intervention Type DRUG

Placebo (matching VNRX-5133 + VNRX-5022)

Interventions

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VNRX-5133

β-lactamase inhibitor

Intervention Type DRUG

VNRX-5022

Approved β-lactam antibiotic

Intervention Type DRUG

Metronidazole

Approved antibiotic and antiprotozoal medication

Intervention Type DRUG

Placebo

Placebo (matching VNRX-5133 + VNRX-5022)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes