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COMPLETED
NCT05065671
PHASE1

Microbiome Derived Metabolism and Pharmacokinetics

Sponsor: Rutgers, The State University of New Jersey

View on ClinicalTrials.gov

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

Interventions

DRUG

Tolcapone 100 MG

Tolcapone 100 mg by mouth once

DRUG

Duloxetine 20 MG

Duloxetine 20 mg by mouth once

Locations (1)

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States