Status:
COMPLETED
Sulforaphane as an Antagonist to Human PXR-mediated Drug-drug Interactions
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Fred Hutchinson Cancer Center
National Institute of General Medical Sciences (NIGMS)
Conditions:
Adverse Drug Interactions
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- Adults from all ethnicities will be encouraged to participate, with our recruitment efforts we expect similar profile as that of the greater Seattle area.
Exclusion
- Exclusion criteria address a mix of medical and practical issues and include:
- Medical history of gastrointestinal, hepatic, or renal disorders
- Pregnancy or lactation
- Known allergies/intolerances to any foods used in the feeding trial
- Weight loss or gain greater than 4.5 kg within the past year
- Major changes in eating habits within the past year (e.g. adoption of a faddish diet)
- Antibiotic use within the past 3 months
- Body weight greater than 150% of desirable
- Exercise patterns that require or result in major changes in diet
- Current use of prescription medication (including oral contraceptives)
- Current use of over-the-counter medications and herbal supplements
- Regular exposure to passive smoke
- Occupational exposure to smoke or organic solvents
- Food dislikes that would preclude participation in the feeding trial
- Alcohol intake of greater than 2 drinks/day (2 drinks=720 mL beer, 240 mL wine, or 9 mL spirits). Additionally, before the trial, participants will have a blood draw to be sent to the UW Medical Center Lab for liver and kidney functions profile and pregnancy test for women. Those with abnormal test results will be excluded as well as pregnant women.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00621309
Start Date
March 1 2008
End Date
September 1 2010
Last Update
September 6 2019
Active Locations (2)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98105
2
UW General Clinical Research Center
Seattle, Washington, United States, 98105