Microbiome Derived Metabolism and Pharmacokinetics

Completed · Phase 1

Conditions studied: Microbial Colonization

In brief

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.

Key facts

Study ID

NCT05065671

Run by

Rutgers, The State University of New Jersey

People needed

17

Starts

2022-02-01

Expected to finish

2025-09-23

Last updated by the study team

2026-04-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 to 65 years of age
• Body mass index between 18.5 - 29.9 kg/m2

You may not qualify if…

• Estimated creatinine clearance < 50 mL/min
• Liver impairment (liver enzymes > 2 times upper limit)
• Antibiotics in the past 3 months
• History of gastrointestinal disease
• History of autoimmune disorder
• Chronic viral infection
• Smoker
• Alcohol intake (defined as having up to 1 drink per day for women and up to 2 drinks per day for men)
• Use of immune modulating medications
• Diabetes mellitus
• Any history or contraindication to the study medications
• Additional exclusion criteria will be based on the FDA approved prescribing information for selected drugs (i.e., contraindications)

Where it is running

• Robert Wood Johnson University Hospital Somerset — Somerville, New Jersey, United States

Full record on ClinicalTrials.gov

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