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NCT01708369 · ClinicalTrials.gov registry record · Phase 1
Alcohol Inhibits Drug Metabolism by Carboxylesterases
A Phase 1 study, sponsored by University of Tennessee.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01708369: Completed Phase 1 study, sponsored by University of Tennessee.
NCT01708369 is a Phase 1 study that has completed, run by University of Tennessee. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01708369, a Phase 1 study, has completed, sponsored by University of Tennessee.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if alcohol is able the affect the body's ability to eliminate two commonly used medication, oseltamivir and aspirin. We hypothesize that drinking alcohol may reduce the body's ability to break down these two medications along with many others.This could affect the amount of drug in the blood which could impact how well these drugs work and whether patients have side effects.
Primary Outcome
For determining if ethanol inhibits hCE1 or hCE2, the primary pharmacokinetic parameter of interest will be the area under the plasma concentration-time curve from time zero to infinity (AUC0-∞) for oseltamivir phosphate and acetylsalicylic acid, respectively. Other pharmacokinetic parameters that will be characterized are maximum plasma concentration (Cmax), time to reach the maximum plasma concentration (tmax), and the elimination rate constant λz. This same pharmacokinetic analysis will also
Interventions
- DRUG Placebo
- DRUG Aspirin
- DRUG Ethanol
- DRUG Oseltamivir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2012-02 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
What the finished NCT01708369 record still lists
NCT01708369 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01708369 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01708369 about?
NCT01708369 is a clinical study titled "Alcohol Inhibits Drug Metabolism by Carboxylesterases". The purpose of this study is to determine if alcohol is able the affect the body's ability to eliminate two commonly used medication, oseltamivir and aspirin. We hypothesize that drinking alcohol may reduce the body's ability to break down these two medications along with many others.This could affe...
What is the current status of trial NCT01708369?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2012-02. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01708369?
The interventions under investigation include: Placebo (DRUG), Aspirin (DRUG), Ethanol (DRUG), Oseltamivir (DRUG).
Who is sponsoring clinical trial NCT01708369?
This trial is sponsored by University of Tennessee, which has 96 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01708369's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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