Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01250535 · ClinicalTrials.gov registry record · Phase 1
Human Cytochrome P450 4F Enzymes and Drug Interactions
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01250535 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 19 participants.
The verdict
NCT01250535, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
Drug-drug interactions play an important role in clinical adverse events due to the prevalence of multi-drug therapy. Co-administration of warfarin and a statin has expanded substantially in the US over the last decades. The purpose of this study is to develop a mechanistic understanding of the role of a drug-metabolizing enzyme, CYP4F2, in the interaction between warfarin and statins. This study will test the hypothesis that lovastatin potentiates the anticoagulant effect of warfarin by inducing vitamin K-metabolizing enzyme CYP4F2 in humans, thus increasing warfarin's anticoagulant effect.
Interventions
- DRUG Placebo
- DRUG Warfarin
- DRUG Lovastatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01250535
The ClinicalTrials.gov registry entry for NCT01250535 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01250535 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01250535 about?
NCT01250535 is a clinical study titled "Human Cytochrome P450 4F Enzymes and Drug Interactions". Drug-drug interactions play an important role in clinical adverse events due to the prevalence of multi-drug therapy. Co-administration of warfarin and a statin has expanded substantially in the US over the last decades. The purpose of this study is to develop a mechanistic understanding of the role...
What is the current status of trial NCT01250535?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2010-12. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01250535?
The interventions under investigation include: Placebo (DRUG), Warfarin (DRUG), Lovastatin (DRUG).
Who is sponsoring clinical trial NCT01250535?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.