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Selective Serotonin and Norepinephrine Reuptake Inhibitor

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

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

MDM-PK Trial 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.Check my eligibility

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.See study design

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.

MDM-PK Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 65 years old.

MDM-PK Trial 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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Drug half-life

Drug peak plasma concentration

+3 more

Other outcome measures

Quantitation of microbiome derived metabolism positive drug metabolites in urine

Quantitation of microbiome derived metabolism positive drugs in urine

MDM-PK Trial Design

2Treatment groups

Experimental Treatment

Group I: TolcaponeExperimental Treatment1 Intervention

Tolcapone 100 mg by mouth once

Group II: DuloxetineExperimental Treatment1 Intervention

Duloxetine 20 mg by mouth once

0 / 1Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,218 Total Patients Enrolled

Media Library

Duloxetine 20 MG (Selective Serotonin and Norepinephrine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05065671 — Phase 1

Microbial Colonization Research Study Groups: Tolcapone, Duloxetine

Microbial Colonization Clinical Trial 2023: Duloxetine 20 MG Highlights & Side Effects. Trial Name: NCT05065671 — Phase 1

Duloxetine 20 MG (Selective Serotonin and Norepinephrine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05065671 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent does Tolcapone 100 MG present a hazard for individuals?

"With limited evidence of the drug's efficacy and safety, Tolcapone 100 MG was evaluated as a 1 on our scale from one to three."

Answered by AI

Is this scientific experiment enrolling individuals aged 80 or older?

"This research mandates that only patients between the ages of 18 and 65 can participate. However, there are 200 studies for minors and 622 trials available to those older than 65 years old."

Answered by AI

How many participants are being monitored for this clinical research?

"Affirmative. Based on the information available from clinicaltrials.gov, this research trial is actively recruiting subjects and first went live on February 1st 2022. As of April 29th, they are looking for 14 participants to be recruited at a single site."

Answered by AI

Could you provide an overview of the past experiments involving Tolcapone 100 MG?

"Presently, 25 trials for Tolcapone 100 MG are in progress. Of these studies, 4 have reached the advanced Phase 3 stage. Moreover, while Redwood City is currently home to most of this research activity, there are 784 sites conducting related analyses around the world."

Answered by AI

Are there any openings for participants in this research endeavor?

"Affirmative. Clinicaltrials.gov records show that this medical experiment, which was initiated on February 1st 2022, is actively recruiting patients for participation. A total of 14 volunteers must be sourced from a single site in order to fulfill the requirements of the trial."

Answered by AI

What population is eligible for enrollment in this investigation?

"To qualify for this medical trial, participants must be suffering from a communicable disorder and within the stipulated age range of 18 to 65. Currently, roughly 14 patients are being considered by the team conducting the study."

Answered by AI

What ailments is Tolcapone 100 MG commonly prescribed to address?

"Tolcapone 100 MG is commonly prescribed for diabetic peripheral neuropathy (DPN). Additionally, this pharmaceutical has been used to alleviate pain and other symptoms related to knee issues, major depressive disorder (MDD), and musculoskeletal system disorders."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Microbiome Derived Metabolism and Pharmacokinetics

Luigi Brunetti 2022. "Microbiome Derived Metabolism and Pharmacokinetics". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05065671.

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