Microbiome Derived Metabolism and Pharmacokinetics

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rutgers, The State University of New Jersey
• Treatments: Duloxetine Hydrochloride; Tolcapone

Criteria

Inclusion Criteria:

• 18 to 65 years of age

• Body mass index between 18.5 - 25.0 kg/m2

Exclusion Criteria

• 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)