Microbiome Effect of Omadacycline on Healthy Volunteers

• Sponsor: University of Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT06030219
• Collaborator: Paratek Pharmaceuticals Inc (Industry)
• Enrollment: 32
• Location: 1
• Arms: 3
• Actual Duration (Months): 34.6
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Omadacycline; Drug: Vancomycin Pill; Drug: Moxifloxacin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Microbiome Effect of Omadacycline on Healthy Volunteers
• Actual Study Start Date: Oct 12, 2020
• Actual Primary Completion Date: Sep 1, 2023
• Actual Study Completion Date: Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Omadacycline 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; 10-day course
Active Comparator: Vancomycin (oral) Vancomycin 125 mg capsules will be taken four times daily for a total of 10 days.	Drug: Vancomycin Pill; 10-day course
Active Comparator: Moxifloxacin Moxifloxacin 400 mg tablets will be taken once per day for a total of 10 days.	Drug: Moxifloxacin; 10-day course

Outcome Measures

Primary Outcome Measures

1. Microbiome changes [During dosing and 30 day follow up period]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Houston	Houston	Texas	United States	77204

Sponsors and Collaborators

• University of Houston
• Paratek Pharmaceuticals Inc

Investigators

• Principal Investigator: Kevin W Garey, Professor and Chair

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 30, 2023

More Information

Publications

None provided.

• Responsible Party: Kevin W. Garey, Professor and Chair, University of Houston
• ClinicalTrials.gov Identifier: NCT06030219
• Other Study ID Numbers: G0505124
• First Posted: Sep 8, 2023
• Last Update Posted: Sep 8, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Kevin W. Garey, Professor and Chair, University of Houston: omadacycline; microbiome; healthy volunteer
• Additional relevant MeSH terms: Moxifloxacin; Vancomycin

Study Results

No Results Posted as of Sep 8, 2023