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NCT00768716 · ClinicalTrials.gov registry record · Phase 4
Effect of Race/Ethnicity and Genes on Acetaminophen Pharmacokinetics
A Phase 4 study, sponsored by Tufts University.
- Completed
- Registry status
- Phase 4
- Development phase
- 95
- Enrollment target
NCT00768716: Completed Phase 4 study, sponsored by Tufts University.
NCT00768716 is a Phase 4 study that has completed, run by Tufts University. The registered enrollment target is 95 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00768716, a Phase 4 study, has completed, sponsored by Tufts University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 95 participants
- Enrollment target
Study Summary
Although acetaminophen is the most commonly used nonprescription drug in the USA, little is known regarding the influence of genes and race/ethnicity on acetaminophen disposition. The investigators long-term goal is to understand the causes of differences in acetaminophen disposition between people that are the result of genetic variation and ethnicity and may predispose individuals to a higher risk of acetaminophen hepatotoxicity. The aim of this particular study is to measure the rate of elimination of acetaminophen via the 3 main pathways (glucuronidation, sulfation and oxidation) in self-identified White-Americans (n=100) and African-Americans (n=100). These rates will then be correlated with selected genetic polymorphisms in genes encoding enzymes involved in acetaminophen metabolism. Two main hypotheses will be tested: 1. African-Americans eliminate acetaminophen more rapidly by glucuronidation than do White-Americans. 2. Elimination via glucuronidation, sulfation, and oxidation in subjects will be significantly correlated with the presence of polymorphisms in the UGT1A6, SULT1A1, and CYP2E1 genes, respectively.
Primary Outcome
Plasma total clearance of acetaminophen in plasma measured by HPLC
Interventions
- DRUG Acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2008-12 |
| Est. Completion | 2013-12 |
| Phase | Phase 4 |
What the finished NCT00768716 record still lists
NCT00768716 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Acetaminophen is the first listed.
NCT00768716 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00768716 about?
NCT00768716 is a clinical study titled "Effect of Race/Ethnicity and Genes on Acetaminophen Pharmacokinetics". Although acetaminophen is the most commonly used nonprescription drug in the USA, little is known regarding the influence of genes and race/ethnicity on acetaminophen disposition. The investigators long-term goal is to understand the causes of differences in acetaminophen disposition between people ...
What is the current status of trial NCT00768716?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 95 participants. The study started on 2008-12. Estimated completion is 2013-12.
What interventions are being tested in trial NCT00768716?
The interventions under investigation include: Acetaminophen (DRUG).
Who is sponsoring clinical trial NCT00768716?
This trial is sponsored by Tufts University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00768716's enrollment target sits among peer trials
95 869th of 2000 higher than 1,130 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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