CompletedPhase 1

Microbiome Derived Metabolism and Pharmacokinetics

United States17 participantsStarted 2022-02-01

Plain-language 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. 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 to 65 years of age * Body mass index between 18.5 - 29.9 kg/m2 Exclusion Criteria * 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 * 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Drug area under the plasma concentration versus time curve (AUC)

Timeframe: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)

Drug peak plasma concentration

Timeframe: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)

Drug trough plasma concentrations

Timeframe: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)

Drug volume of distribution

Timeframe: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)

Drug half-life

Timeframe: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)

Drug plasma clearance

Timeframe: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)

Trial details

NCT IDNCT05065671

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-23

View on ClinicalTrials.gov More Microbial Colonization trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Drug area under the plasma concentration versus time curve (AUC)

Timeframe: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)

Drug peak plasma concentration

Timeframe: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)

Drug trough plasma concentrations

Timeframe: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)

Drug volume of distribution

Timeframe: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)

Drug half-life

Timeframe: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)

Drug plasma clearance

Timeframe: After a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)