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NCT06601257 · ClinicalTrials.gov registry record · Phase 1
Vancomycin Dose Optimization in Obesity
A Phase 1 study of Pharmacokinetics and Pharmacodynamics, sponsored by University of Michigan.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT06601257: Recruiting Phase 1 study of Pharmacokinetics and Pharmacodynamics, sponsored by University of Michigan.
NCT06601257 is a Phase 1 study of Pharmacokinetics and Pharmacodynamics that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06601257, a Phase 1 study of Pharmacokinetics and Pharmacodynamics, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to learn how to optimize vancomycin dosing in obese adults based on weight and kidney function. It will also assess the safety of different vancomycin dosing strategies. The main questions it aims to answer are: Does dosing vancomycin based on kidney function provide better drug exposure than dosing based on weight? What medical or safety issues arise when vancomycin is dosed according to weight versus kidney function? Participants will be randomized into two groups. One group will receive vancomycin doses based on their weight, while the other will receive doses based on their kidney function. Participants will: Receive a single dose of vancomycin based on either their weight or kidney function after pretreatment with antihistamines Provide blood and urine samples at specific times for pharmacokinetic analysis Undergo body composition measurements using DEXA scans and other methods Visit the clinic for physical exams, medical history, and laboratory tests
Primary Outcome
Number of participants with a vancomycin area under the concentration-time curve that is between 400 h\*mg/L and 600 h\*mg/L after a single dose.
Conditions Studied
Interventions
- DRUG Vancomycin (IV)
Study Locations (1)
Michigan
- Michigan Clinical Research Unit - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2025-04-01 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
What NCT06601257 shows while recruiting
NCT06601257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Pharmacokinetics and Pharmacodynamics appearing as the primary indexed condition, and to 1 intervention - of which Vancomycin (IV) is the first listed.
NCT06601257 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06601257 about?
NCT06601257 is a clinical study titled "Vancomycin Dose Optimization in Obesity". The goal of this clinical trial is to learn how to optimize vancomycin dosing in obese adults based on weight and kidney function. It will also assess the safety of different vancomycin dosing strategies. The main questions it aims to answer are: Does dosing vancomycin based on kidney function prov...
What is the current status of trial NCT06601257?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2025-04-01. Estimated completion is 2026-06.
What conditions does trial NCT06601257 study?
This clinical trial studies the following conditions: Pharmacokinetics and Pharmacodynamics.
What interventions are being tested in trial NCT06601257?
The interventions under investigation include: Vancomycin (IV) (DRUG).
Who is sponsoring clinical trial NCT06601257?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06601257 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pharmacokinetics and Pharmacodynamics
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 NCT06601257's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
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