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NCT06030219 Clinical Trial

Microbiome Effect of Omadacycline on Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:
Microbiome Effect of Omadacycline on Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06030219
Other study ID # G0505124
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 12, 2020
Est. completion date September 1, 2023

Study information
Verified date September 2023
Source University of Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date September 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility All volunteers will be considered healthy based on medical history, none will have a history of cardiovascular, gastrointestinal, hepatic, or renal disease. Subjects will not have taken an antibiotic for at least three months prior to enrollment. Patients will not have taken a probiotic for at least a month prior to enrollment and during the entire study period.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Omadacycline
10-day course
• Vancomycin Pill
10-day course
• Moxifloxacin
10-day course

Locations
Country Name City State
United States University of Houston Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
University of Houston Paratek Pharmaceuticals Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Microbiome changes Metagenomic changes (16S rRNA) and qPCR for individual bacterial species During dosing and 30 day follow up period
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