Microbiome Effect of Omadacycline on Healthy Volunteers

University of Houston

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Moxifloxacin; Drug: Vancomycin Pill; Drug: Omadacycline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06030219

G0505124

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

32 participants in 3 patient groups

Omadacycline

Experimental group

Description:

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

Treatment:

Drug: Omadacycline

Vancomycin (oral)

Active Comparator group

Description:

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

Treatment:

Drug: Vancomycin Pill

Moxifloxacin

Active Comparator group

Description:

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

Treatment:

Drug: Moxifloxacin