Microbiome Effect of Omadacycline on Healthy Volunteers

NCT06030219 | Completed Phase 1 FDA Drug

• 1 other identifier: G0505124
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

omadacycline; microbiome; healthy volunteer

Outcome Measures

Primary Outcomes (1)

• Microbiome changes

  Metagenomic changes (16S rRNA) and qPCR for individual bacterial species

  During dosing and 30 day follow up period

Study Arms (3)

Omadacycline

EXPERIMENTAL

Subjects will receive 3 tablets on day 1 and day 2 (450 mg) followed by 2 tablets (300 mg) for days 3 through 10.

Drug: Omadacycline

Vancomycin (oral)

ACTIVE COMPARATOR

Vancomycin 125 mg capsules will be taken four times daily for a total of 10 days.

Drug: Vancomycin Pill

Moxifloxacin

ACTIVE COMPARATOR

Moxifloxacin 400 mg tablets will be taken once per day for a total of 10 days.

Drug: Moxifloxacin

Interventions

Omadacycline DRUG

10-day course

Omadacycline

Vancomycin Pill DRUG

10-day course

Vancomycin (oral)

Moxifloxacin DRUG

10-day course

Moxifloxacin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Inclusion. All volunteers will be considered healthy based on medical history Exclusion. Patients will be excluded if they report any of the following: * Cardiovascular disease * Gastrointestinal disease * Hepatic or renal disease * Receipt of an antibiotic for at least three months prior to enrollment. * Receipt of a probiotic for at least a month prior to enrollment and during the entire study period.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Houston: lead
• Paratek Pharmaceuticals Inc: collaborator

Study Sites (1)

University of Houston

Houston, Texas, 77204, United States

Location

Related Publications (3)

• Ayele H, Jo J, Begum K, Hu C, Le TM, Alam MJ, Eubank TA, Haidacher SJ, Horvath TD, Hanson BM, Garey KW. A Randomized Phase 1 Study Investigating Gut Microbiome Changes With Moxifloxacin vs Oral Vancomycin: Implications for Clostridioides difficile Risk. J Infect Dis. 2025 Dec 20;232(6):1446-1456. doi: 10.1093/infdis/jiaf512.

  PMID: 41081530 DERIVED

• Jo J, Hu C, Horvath TD, Haidacher SJ, Begum K, Alam MJ, Garey KW. Phase I trial comparing bile acid and short-chain fatty acid alterations in stool collected from human subjects treated with omadacycline or vancomycin. Antimicrob Agents Chemother. 2025 Feb 13;69(2):e0125124. doi: 10.1128/aac.01251-24. Epub 2025 Jan 17.

  PMID: 39819014 DERIVED

• Jo J, Hu C, Begum K, Wang W, Le TM, Agyapong S, Hanson BM, Ayele H, Lancaster C, Jahangir Alam M, Gonzales-Luna AJ, Garey KW. Fecal Pharmacokinetics and Gut Microbiome Effects of Oral Omadacycline Versus Vancomycin in Healthy Volunteers. J Infect Dis. 2024 Jan 12;229(1):273-281. doi: 10.1093/infdis/jiad537.

  PMID: 38051631 DERIVED

MeSH Terms

Interventions

omadacycline; Vancomycin; Moxifloxacin

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kevin W Garey

  Professor and Chair

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: October 12, 2020
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)