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Microbiome Derived Metabolism and Pharmacokinetics
Sponsor: Rutgers, The State University of New Jersey
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.
Official title: Incorporating Drug Metabolism by the Human Gut Microbiome Into Personalized Medicine
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
17
Start Date
2022-02-01
Completion Date
2025-09-23
Last Updated
2026-04-29
Healthy Volunteers
Yes
Conditions
Interventions
Tolcapone 100 MG
Tolcapone 100 mg by mouth once
Duloxetine 20 MG
Duloxetine 20 mg by mouth once
Locations (1)
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, United States