RECRUITING

Microbiome Derived Metabolism and Pharmacokinetics

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-02-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05065671

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 to 65 years of age
  2. * Body mass index between 18.5 - 29.9 kg/m2
  3. * Estimated creatinine clearance \< 50 mL/min
  4. * Liver impairment (liver enzymes \> 2 times upper limit)
  5. * Antibiotics in the past 3 months
  6. * History of gastrointestinal disease
  7. * History of autoimmune disorder
  8. * Chronic viral infection
  9. * Smoker
  10. * Alcohol intake (defined as having up to 1 drink per day for women and up to 2 drinks per day for men)
  11. * Use of immune modulating medications
  12. * Diabetes mellitus
  13. * Any history or contraindication to the study medications
  14. * Additional exclusion criteria will be based on the FDA approved prescribing information for selected drugs (i.e., contraindications)
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Luigi Brunetti, PhD
CONTACT
908-595-2645
luigi.brunetti@rutgers.edu
Mohamed Donia, PhD
CONTACT
609-258-5870
donia@princeton.edu

Study Locations (Sites)

Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-02-01
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Microbial Colonization