Healthy VolunteersPhase 1NCT06030219
Microbiome Effect of Omadacycline on Healthy Volunteers
A Phase 1 study testing Omadacycline, Vancomycin Pill and Moxifloxacin in people with Healthy Volunteers, run by University of Houston at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Omadacycline, Vancomycin Pill and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2020to 1 Sep 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Omadacycline, Vancomycin Pill, Moxifloxacin
- Keywords
- omadacycline, microbiome, healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmadacyclineDrug
10-day course
Vancomycin PillDrug
10-day course
MoxifloxacinDrug
10-day course
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Omadacycline |
| Vancomycin (oral) | Active comparator | Vancomycin 125 mg capsules will be taken four times daily for a total of 10 days. Receives: Drug: Vancomycin Pill |
| Moxifloxacin | Active comparator | Moxifloxacin 400 mg tablets will be taken once per day for a total of 10 days. Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome changes
Metagenomic changes (16S rRNA) and qPCR for individual bacterial species
Measured: During dosing and 30 day follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start12 Oct 2020
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Paratek Pharmaceuticals Inc
- Responsible party
- Principal investigator, Kevin W. Garey, University of Houston
- Investigators
- Kevin W Garey, Principal investigator, Professor and Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030219
- Sponsor's protocol ID
- G0505124
- Status last verified
- Mar 2025
- First submitted
- 1 Sep 2023
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Metagenomic and metadata will be shared by posting to relevant biorepositories or upon reasonable requests from external investigators.
Publications
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.
PubMed 41081530Jo 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.
PubMed 39819014Jo 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.
PubMed 38051631
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome Effect of Omadacycline on Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06030219
- Acronym / sponsor ID
- G0505124
- Conditions
- Healthy Volunteers
- Keywords
- omadacycline, microbiome, healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- Paratek Pharmaceuticals Inc
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Omadacycline | Experimental | Drug: OmadacyclineSubjects will receive 3 tablets on day 1 and day 2 (450 mg) followed by 2 tablets (300 mg) for days 3 through 10. |
| Vancomycin (oral) | Active comparator | Drug: Vancomycin PillVancomycin 125 mg capsules will be taken four times daily for a total of 10 days. |
| Moxifloxacin | Active comparator | Drug: MoxifloxacinMoxifloxacin 400 mg tablets will be taken once per day for a total of 10 days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omadacycline10-day course | Drug | Omadacycline |
| Vancomycin Pill10-day course | Drug | Vancomycin (oral) |
| Moxifloxacin10-day course | Drug | Moxifloxacin |
Primary outcome
Microbiome changes
Time frame: During dosing and 30 day follow up period
Metagenomic changes (16S rRNA) and qPCR for individual bacterial species
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Derived from this study: PubMed 41081530Ayele 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.
- Derived from this study: PubMed 39819014Jo 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.
- Derived from this study: PubMed 38051631Jo 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.
- Individual participant dataSharing planned: Yes. Metagenomic and metadata will be shared by posting to relevant biorepositories or upon reasonable requests from external investigators.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin W Garey principal investigator
Professor and Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omadacycline, Vancomycin Pill and Moxifloxacin in people with Healthy Volunteers, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome changes (time frame: During dosing and 30 day follow up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06030219, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.