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NCT Number: NCT06462326

A Study to Compare the Effect of Omadacycline Versus Moxifloxacin in Healthy Adult Volunteers

This is a randomized (1:1), double-blind, double-dummy, phase I study to compare the effects of Omadacycline versus Moxifloxacin on gut microbiota and the resistomes in healthy adult volunteers.The study consists of 3 phases: Screening, double-blind treatment, and follow-up. Healthy volunteers aged 18-40 years, who meet entry criteria, are randomly assigned to a treatment group using an Interactive Voice Response System/Interactive Web Response System (IxRS) and receive the first dose of the study drug.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

About this study

The study consists of 3 phases: Screening, double-blind treatment, and follow-up. Healthy volunteers aged 18-40 years, who meet entry criteria, are randomly assigned to a treatment group using an Interactive Voice Response System/Interactive Web Response System (IxRS) and receive the first dose of the study drug.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Sign an Informed Consent Form (ICF) prior to the commencement of any study-related procedures.
  • Chinese healthy male and female subjects aged between 18 and 40 years (inclusive).
  • Body mass index (BMI) between 18.5 and 23.9 kg/m2 (inclusive).
  • Complete the stool sample collections required during screening.

Exclusion criteria

  • Subjects with clinically significant medical history of cardiovascular, hepatic, renal, gastrointestinal or psychiatric conditions, or any other condition as deemed by the investigators that may potentially jeopardize subject safety or impact study outcomes.
  • Subjects who have undergone any major surgery within 4 weeks prior to the first dose of study drug administration.
  • Subjects who have previously undergone gastrointestinal surgery that may affect the absorption of the study drug (eg. Intestinal resection surgery, fistula surgery).
  • During screening, subjects with positive tests for hepatitis C antibodies, hepatitis B surface antigen, or hepatitis B virus (HBV) DNA or HBV RNA, or known positive tests for human immunodeficiency virus (HIV).
  • Subjects with Fridericia-corrected QT interval (QTcF) > 450 milliseconds (males) or > 470 milliseconds (females); or known to have long QT syndrome; or using medications that may cause arrhythmia or prolong QT interval, and/or experiencing tachyarrhythmia.
  • Subjects with a history of irritable bowel syndrome (with or without constipation) -

Treatment and study plan

Moxifloxacin Oral Tablet

Drug

400mg per tablet

Other names: Avelox

Omadacycline Oral Tablet

Drug

150 mg per tablet

Other names: NUZYRA

Primary outcomes

  1. Changes in the types of microbial resistomes.

    Time frame: 3months

    Metagenome will be extracted from fecal samples of ME population and subjected to second-generation high-throughput sequencing. Bioinformatics will be employed to study the changes in the types of resistance-related genes of microbiota during the drug administration process in the microbiologically evaluable population. This outcome is based on second-generation high-throughput sequencing. the outcome is to test the genes to confirm the changes in types of microbial resistors in different stages.

  2. Changes in the quantity of microbial resistomes.

    Time frame: 3months

    Metagenome will be extracted from fecal samples of ME population and subjected to second-generation high-throughput sequencing. Bioinformatics will be employed to study the changes in the quantity of resistance-related genes of microbiota during the drug administration process in the microbiologically evaluable population.This outcome is based on second-generation high-throughput sequencing. the outcome is to test the gene to confirm the changes in quantity of microbial resistors in different stages .

  3. Changes in the abundance of microbial resistomes.

    Time frame: 3months

    Metagenome will be extracted from fecal samples of ME population and subjected to second-generation high-throughput sequencing. Bioinformatics will be employed to study the changes in the abundance of resistance-related genes of microbiota during the drug administration process in the microbiologically evaluable population.This outcome is based on second-generation high-throughput sequencing. the outcome is to test the genes to confirm the changes in abundance of microbial resistors in different stages.

Secondary outcomes

  1. Changes in the microbial composition

    Time frame: 3months

    Metagenome will be extracted from fecal samples of ME population and subjected to second-generation high-throughput sequencing. Principal component analysis will be employed to study the changes in the structure of microbiota during the drug administration process in the microbiologically evaluable population. This outcome is based on the result of principal component analysis to confirm the microbial composition in different stages based on different genes.

  2. Changes in the microbial functionality

    Time frame: 3months

    Metagenome will be extracted from fecal samples of ME population and subjected to second-generation high-throughput sequencing. Principal coordinates analysis will be employed to study the changes in the structure of microbiota during the drug administration process in the microbiologically evaluable population. This outcome is based on result of principal coordinates analysis to confirm the microbial functionality in different stages based on different genes.

Sponsors and collaborators

Lead sponsor

Zai Lab (Hong Kong), Ltd.

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind Study to Compare the Effect of Omadacycline PO Versus Moxifloxacin PO on the Gut Microbiota in Healthy Adult Volunteers

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 17, 2024
Registry last updated
Nov 1, 2024

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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