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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05065671
The ClinicalTrials.gov registry entry for NCT05065671 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,654-participant average among 20 other Microbial Colonization trials with a reported enrollment target (100% lower). The listed sponsor is Rutgers, The State University of New Jersey, which has 413 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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