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NCT00621309 · ClinicalTrials.gov registry record · Phase 1
Sulforaphane as an Antagonist to Human PXR-mediated Drug-drug Interactions
A Phase 1 study of Adverse Drug Interactions, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
- 2
- Study locations
NCT00621309 is a Phase 1 study of Adverse Drug Interactions that has completed, run by University of Washington. The registered enrollment target is 29 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT00621309, a Phase 1 study of Adverse Drug Interactions, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
- 2
- Study locations
Study Summary
Adverse drug-drug interactions (DDIs) are responsible for approximately 3% of all hospitalizations in the US, perhaps costing more than $1.3 billion per year. One of the most common causes of DDIs is the when one drug alters the metabolism of another. A key enzyme in the liver and intestine, called "cytochrome P450 3A4 (CYP3A4) is generally considered to be the most important drug metabolizing enzyme. The gene for CYP3A4 can be 'turned on' by the presence of certain other drugs, resulting in much higher levels of CYP3A4 in the liver and intestine. Thus, when a drug that induces CYP3A4 is given with or before another drug that is metabolized by 3A4, a 'drug-drug' interaction occurs because the first drug (the inducer) greatly changes the rate at which the second drug (CYP3A4 substrate) is removed from the body. Many drugs increase CYP3A4 activity by binding to a receptor called the Pregnane-X-Receptor (PXR), which is a major switch that controls the expression of the CYP3A4 gene. Using human liver cells we have demonstrated that sulforaphane (SFN), found in broccoli, can block drugs from activating the PXR receptor, thereby inhibiting the switch that causes CYP3A4 induction. The purpose of this project is to determine if SFN can be used to block adverse DDIs that occur when drugs bind to and activate the PXR receptor and subsequently induce CYP3A4 activity. We will recruit 24 human volunteers to participate in the study. This project will determine whether SFN can prevent the drug Rifampin from binding to PXR and increasing CYP3A4 activity in humans following oral administration of SFN (broccoli sprout extract). The rate of removal of a small dose of the drug midazolam will be used to determine the enzymatic activity of CYP3A4 before and following treatment with Rifampin, in the presence or absence of SFN, since midazolam is only eliminated from the bloodstream by CYP3A4. . We predict that SFN will prevent the increase in midazolam clearance (metabolism) that normall
Conditions Studied
Interventions
- DRUG Rifampicin
- DIETARY_SUPPLEMENT sulforaphane plus rifampicin
- DIETARY_SUPPLEMENT sulforaphane alone
Study Locations (2)
Washington
- Fred Hutchinson Cancer Research Center - Seattle
- UW General Clinical Research Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2008-03 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00621309
The ClinicalTrials.gov registry entry for NCT00621309 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Adverse Drug Interactions appearing as the primary indexed condition, and to 3 interventions - of which Rifampicin is the first listed.
NCT00621309 reports 2 study locations spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT00621309 about?
NCT00621309 is a clinical study titled "Sulforaphane as an Antagonist to Human PXR-mediated Drug-drug Interactions". Adverse drug-drug interactions (DDIs) are responsible for approximately 3% of all hospitalizations in the US, perhaps costing more than $1.3 billion per year. One of the most common causes of DDIs is the when one drug alters the metabolism of another. A key enzyme in the liver and intestine, called ...
What is the current status of trial NCT00621309?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2008-03. Estimated completion is 2010-09.
What conditions does trial NCT00621309 study?
This clinical trial studies the following conditions: Adverse Drug Interactions.
What interventions are being tested in trial NCT00621309?
The interventions under investigation include: Rifampicin (DRUG), sulforaphane plus rifampicin (DIETARY_SUPPLEMENT), sulforaphane alone (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00621309?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00621309 being conducted?
This trial has 2 study locations across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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