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Completed

NCT Number: NCT03332732

VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers

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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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRAHS

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VNRX-5133

Drug

β-lactamase inhibitor

VNRX-5022

Drug

Approved β-lactam antibiotic

Metronidazole

Drug

Approved antibiotic and antiprotozoal medication

Placebo

Drug

Placebo (matching VNRX-5133 + VNRX-5022)

Primary outcomes

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

    Time frame: 0-48 hours

    Cmax

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

    Time frame: 0-48 hours

    AUCinf

Secondary outcomes

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

    Time frame: 0-48 hours

    Cmax

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

    Time frame: 0-48 hours

    AUCinf

  3. Number of Subjects with Treatment Emergent Adverse Events

    Time frame: 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.

  4. Accumulation of VNRX-5133 + VNRX-5022 following multiple dose administration

    Time frame: Part 2: 10 days

    Trough concentration levels from Day 1 - Day 10

Other outcomes

  1. Bactericidal titers (Part 2)

    Time frame: 10 days

    To evaluate serum and urine bactericidal activity at peak and trough concentrations following multiple dose administration of VNRX-5133 + VNRX-5022

Sponsors and collaborators

Lead sponsor

Venatorx Pharmaceuticals, Inc.

Industry

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Nov 6, 2017
Registry last updated
Oct 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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