Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05065671 · ClinicalTrials.gov registry record · Phase 1
Microbiome Derived Metabolism and Pharmacokinetics
A Phase 1 study of Microbial Colonization, sponsored by Rutgers, The State University of New Jersey.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT05065671: Recruiting Phase 1 study of Microbial Colonization, sponsored by Rutgers, The State University of New Jersey.
NCT05065671 is a Phase 1 study of Microbial Colonization that is actively recruiting participants, run by Rutgers, The State University of New Jersey. The registered enrollment target is 14 participants, below the 12,654-participant average among 20 other Microbial Colonization trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05065671, a Phase 1 study of Microbial Colonization, is actively recruiting participants, sponsored by Rutgers, The State University of New Jersey.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
We will calculate the plasma area under the curve for the microbiome derived metabolism positive probe drugs
Conditions Studied
Interventions
- DRUG Tolcapone 100 MG
- DRUG Duloxetine 20 MG
Study Locations (1)
New Jersey
- Robert Wood Johnson University Hospital Somerset - Somerville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2022-02-01 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 1 |
What NCT05065671 shows while recruiting
NCT05065671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 12,654-participant average among 20 other Microbial Colonization trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Microbial Colonization appearing as the primary indexed condition, and to 2 interventions - of which Tolcapone 100 MG is the first listed.
NCT05065671 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT05065671 about?
NCT05065671 is a clinical study titled "Microbiome Derived Metabolism and Pharmacokinetics". 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 t...
What is the current status of trial NCT05065671?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2022-02-01. Estimated completion is 2025-12-31.
What conditions does trial NCT05065671 study?
This clinical trial studies the following conditions: Microbial Colonization.
What interventions are being tested in trial NCT05065671?
The interventions under investigation include: Tolcapone 100 MG (DRUG), Duloxetine 20 MG (DRUG).
Who is sponsoring clinical trial NCT05065671?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05065671 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Microbial Colonization
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05065671's enrollment target sits among peer trials
14 18th of 20 higher than 3 of 20 other Microbial Colonization trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Microbial Colonization trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome
RECRUITING · Phase 1
-
Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment
RECRUITING · Phase 1
-
Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant
ACTIVE NOT RECRUITING · Phase 1
-
Changes in Microbial Status From Dentate, Edentulous and After Dental Implant Placement
RECRUITING
-
Skin Preparation for Elective Foot and Ankle Surgery
RECRUITING · Phase 4
-
Effects of Mouthrinse on the Microbiome of the Oral Cavity and GI Tract
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02523092 · 14 participants · Phase 4
Use of CXCL9 as a Biomarker of Acthar Efficacy
- NCT04263285 · 14 participants · NA
Treatment of Depression Post-SCI
- NCT04743271 · 14 participants · NA
Food and Circadian Timing
- NCT05183048 · 14 participants · Early Phase 1
Comparison of 89Zr Panitumumab and (18)F-Fluorodeoxyglucose to Identify Head and Neck Squamous Cell Carcinoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT06358040 · started 2026-10 · NA
Opioid Dispenser for Microdiscectomy/Laminectomy