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Microbiome Effect of Omadacycline on Healthy Volunteers

NCT06030219 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-03-25

No results posted yet for this study

Summary

The goal of this study is to assess microbiome changes associated with omadacycline vs. comparators (moxifloxacin or oral vancomycin). Using a phase I study design, healthy volunteers aged 18-40 years will be given a 10-day course of either omadacycline 450 mg days 1 and 2 followed by 300 mg PO once daily, moxifloxacin 400 mg once daily, or oral vancomycin 125 mg given four times daily. Stool will be collected at baseline, daily during therapy, and at two follow-up time periods (days 13-14 and days 30-32). DNA will be extracted from stool and used for qPCR biomass and microbial metagenomic experiments. Results from the study will provide definitive data on the microbiome effects of omadacycline versus comparator antibiotics.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Omadacycline

10-day course

DRUG

Vancomycin Pill

10-day course

DRUG

Moxifloxacin

10-day course

Sponsors & Collaborators

  • Paratek Pharmaceuticals Inc

    collaborator INDUSTRY

  • University of Houston

    lead OTHER

Principal Investigators

  • Kevin W Garey · Professor and Chair

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-12
Primary Completion
2023-09-01
Completion
2023-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06030219 on ClinicalTrials.gov