Microbial ColonizationPhase 1MDM-PKNCT05065671
Microbiome Derived Metabolism and Pharmacokinetics
A Phase 1 study testing Tolcapone 100 MG and Duloxetine 20 MG in people with Microbial Colonization, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The investigators will perform single-dose pharmacokinetic (PK) studies in humans following administration of drugs with known microbiome derived metabolism (MDM) in parallel with preclinical studies. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- What is being tested?
- Tolcapone 100 MG and Duloxetine 20 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2022to 23 Sep 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age
- Body mass index between 18.5 - 29.9 kg/m2
Who cannot join
- Estimated creatinine clearance < 50 mL/min
- Liver impairment (liver enzymes > 2 times upper limit)
- Antibiotics in the past 3 months
- History of gastrointestinal disease
- History of autoimmune disorder
- Chronic viral infection
Show all 12Show fewer
- Smoker
- Alcohol intake (defined as having up to 1 drink per day for women and up to 2 drinks per day for men)
- Use of immune modulating medications
- Diabetes mellitus
- Any history or contraindication to the study medications
- Additional exclusion criteria will be based on the FDA approved prescribing information for selected drugs (i.e., contraindications)
Trial locations and contacts
1 site in 1 country.
United States1 site
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876
About this study
Official title: Incorporating Drug Metabolism by the Human Gut Microbiome Into Personalized Medicine
The investigators will perform single-dose pharmacokinetic (PK) studies in humans following administration of drugs with known microbiome derived metabolism (MDM) in parallel with preclinical studies. By directly comparing laboratory measurements to clinical results, the investigators will be able to confirm the relevance of MDM in vivo, create microbiome-dependent PK profiles of the MDM positive drugs, and establish methodology to capture the contribution of MDM to inter-individual variability in clinical drug PK profiles.
Read the detailed description
The human gut microbiome has been shown to play an important role in the observed inter-individual variability in therapeutic response, including both efficacy and toxicity. One of the mechanisms by which the gut microbiome exerts these effects is through the direct biochemical transformation of orally administered drugs into more or less active or toxic metabolites, termed herein microbiome-derived drug metabolism (MDM). Recent systematic studies have revealed an enormous and largely unexplored biochemical capacity of human gut bacteria - cultured in ex vivo microbial communities or as single isolates - to metabolize dozens of orally administered drugs but the clinical relevance of the observed MDM remains unmapped. This gap in knowledge is a result of overt disconnect between preclinical and clinical studies: MDM studies performed in the laboratory are removed from direct clinical comparisons, and human studies performed during drug development and therapeutic interventions almost completely ignore microbiome contribution. Moreover, there is currently a lack standardized experimental methods and mathematical models to start incorporating MDM into clinical decisions. Our PK studies are aimed at developing such strategies into clinical practice.
- Conditions
- Microbial Colonization
- Being tested
- Tolcapone 100 MG, Duloxetine 20 MG
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tolcapone 100 MGDrug
Tolcapone 100 mg by mouth once
Duloxetine 20 MGDrug
Duloxetine 20 mg by mouth once
| Study group | Role | What they receive |
|---|---|---|
| Tolcapone | Experimental | Tolcapone 100 mg by mouth once Receives: Drug: Tolcapone 100 MG |
| Duloxetine | Experimental | Duloxetine 20 mg by mouth once Receives: Drug: Duloxetine 20 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug area under the plasma concentration versus time curve (AUC)
We will calculate the plasma area under the curve for the microbiome derived metabolism positive probe drugs
Measured: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)
Drug peak plasma concentration
We will measure the peak plasma concentration for microbiome derived metabolism positive probe drugs
Measured: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)
Drug trough plasma concentrations
We will measure the trough plasma concentration for microbiome derived metabolism positive probe drugs
Measured: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)
Drug volume of distribution
We will calculate the volume of distribution for microbiome derived metabolism positive probe drugs
Measured: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)
Drug half-life
We will calculate drug half-life for microbiome derived metabolism positive probe drugs
Measured: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)
Drug plasma clearance
We will calculate drug plasma clearance for each microbiome derived metabolism positive drug.
Measured: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start1 Feb 2022
- Primary completion23 Sep 2025
- Study completion23 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Brunetti, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065671
- Sponsor's protocol ID
- Pro2021000945
- Acronym
- MDM-PK
- Status last verified
- Apr 2026
- First submitted
- 13 Sep 2021
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Drug Metabolism by the Human Gut Microbiome Into Personalized Medicine
- ClinicalTrials.gov ID
- NCT05065671
- Acronym / sponsor ID
- MDM-PK / Pro2021000945
- Conditions
- Microbial Colonization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 23 Sep 2025 (actual)
- First posted
- 4 Oct 2021 (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 investigators will perform single-dose pharmacokinetic (PK) studies in humans following administration of drugs with known microbiome derived metabolism (MDM) in parallel with preclinical studies. By directly comparing laboratory measurements to clinical results, the investigators will be able to confirm the relevance of MDM in vivo, create microbiome-dependent PK profiles of the MDM positive drugs, and establish methodology to capture the contribution of MDM to inter-individual variability in clinical drug PK profiles.
Detailed description
The human gut microbiome has been shown to play an important role in the observed inter-individual variability in therapeutic response, including both efficacy and toxicity. One of the mechanisms by which the gut microbiome exerts these effects is through the direct biochemical transformation of orally administered drugs into more or less active or toxic metabolites, termed herein microbiome-derived drug metabolism (MDM). Recent systematic studies have revealed an enormous and largely unexplored biochemical capacity of human gut bacteria - cultured in ex vivo microbial communities or as single isolates - to metabolize dozens of orally administered drugs but the clinical relevance of the observed MDM remains unmapped. This gap in knowledge is a result of overt disconnect between preclinical and clinical studies: MDM studies performed in the laboratory are removed from direct clinical comparisons, and human studies performed during drug development and therapeutic interventions almost completely ignore microbiome contribution. Moreover, there is currently a lack standardized experimental methods and mathematical models to start incorporating MDM into clinical decisions. Our PK studies are aimed at developing such strategies into clinical practice.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tolcapone | Experimental | Drug: Tolcapone 100 MGTolcapone 100 mg by mouth once |
| Duloxetine | Experimental | Drug: Duloxetine 20 MGDuloxetine 20 mg by mouth once |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 to 65 years of age
- Body mass index between 18.5 - 29.9 kg/m2
Key exclusion criteria (12 listed)
- Estimated creatinine clearance < 50 mL/min
- Liver impairment (liver enzymes > 2 times upper limit)
- Antibiotics in the past 3 months
- History of gastrointestinal disease
- History of autoimmune disorder
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 |
|---|---|---|
| Tolcapone 100 MGTolcapone 100 mg by mouth once | Drug | Tolcapone |
| Duloxetine 20 MGDuloxetine 20 mg by mouth once | Drug | Duloxetine |
Primary outcome
Drug area under the plasma concentration versus time curve (AUC)
Time frame: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)
We will calculate the plasma area under the curve for the microbiome derived metabolism positive probe drugs
Drug peak plasma concentration
Time frame: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)
We will measure the peak plasma concentration for microbiome derived metabolism positive probe drugs
Drug trough plasma concentrations
Time frame: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)
We will measure the trough plasma concentration for microbiome derived metabolism positive probe drugs
Drug volume of distribution
Time frame: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)
We will calculate the volume of distribution for microbiome derived metabolism positive probe drugs
Drug half-life
Time frame: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)
We will calculate drug half-life for microbiome derived metabolism positive probe drugs
Drug plasma clearance
Time frame: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)
We will calculate drug plasma clearance for each microbiome derived metabolism positive drug.
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 29 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Microbial Colonization
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Active, not recruitingPhase 1/2
Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age
HIV-1-infection
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Recruiting
High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases - Fit4MedRob-Acute MND Project
Critical Illness Myopathy, Guillain Barré Syndrome
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tolcapone 100 MG and Duloxetine 20 MG in people with Microbial Colonization, run by Rutgers, The State University of New Jersey 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?
The sponsor lists 2 inclusion and 12 exclusion criteria. 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 29 Apr 2026. 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?
Drug area under the plasma concentration versus time curve (AUC) (time frame: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.