Microbiome Influence on Drug Metabolism (MDM-PK Trial)

Phase 1

Recruiting

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 to 65 years of age

Be older than 18 years old

Must not have

Estimated creatinine clearance < 50 mL/min

Use of immune modulating medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will study how drugs are metabolized by the microbiome in humans, in parallel with preclinical studies. The investigators will be able to confirm the relevance of microbiome-derived metabolism in vivo, create microbiome-dependent PK profiles of the drugs, and establish methodology to capture the contribution of microbiome-derived metabolism to inter-individual variability in clinical drug PK profiles.

Who is the study for?

This trial is for healthy adults aged 18-65 with a BMI of 18.5-29.9 kg/m2 who haven't taken antibiotics in the last 3 months, don't smoke, and have no history of gastrointestinal disease or chronic viral infections. They should not be heavy drinkers or have liver impairment, diabetes, autoimmune disorders, or any contraindications to study medications.

What is being tested?

The study tests how the body processes Tolcapone and Duloxetine—drugs affected by gut bacteria—by comparing lab results with those from human participants. The goal is to understand individual differences in drug metabolism due to microbiome interactions.

What are the potential side effects?

Potential side effects may include issues related to liver function (since Tolcapone can affect it), as well as nausea, dry mouth, fatigue commonly associated with Duloxetine use. Side effects will vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is reduced with a creatinine clearance below 50 mL/min.

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I am taking medication that affects my immune system.

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I have a long-term viral infection.

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I have diabetes.

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My liver enzymes are more than twice the normal limit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after a single dose of a microbiome derived metabolism positive drug (over an 8 hour period for each drug) for reporting.