Status:
COMPLETED
Microbiome Effect of Omadacycline on Healthy Volunteers
Lead Sponsor:
University of Houston
Collaborating Sponsors:
Paratek Pharmaceuticals Inc
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06030219
Start Date
October 12 2020
End Date
September 1 2023
Last Update
March 25 2025
Active Locations (1)
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1
University of Houston
Houston, Texas, United States, 77204