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drugset / Trial / NCT05065671

Microbiome Derived Metabolism and Pharmacokinetics

NCT05065671 ↗

Phase 1 Completed 17 enrolled Rutgers, The State University of New Jersey
Non-randomizedCrossoverOpen-labelOther

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.

Timeline

Start
2022-02-01
Primary completion
2025-09-23
Completion
2025-09-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Duloxetine Small molecule 20 mg Oral
Subject Tolcapone Unknown 100 mg Oral

Indications

No indication recorded.