Know Cancer

forgot password

Phase I Clinical Trial to Evaluate the Efficacy of Sulforaphane as an Antagonist to Human PXR-mediated Drug-drug Interactions

Phase 1
18 Years
40 Years
Open (Enrolling)
Adverse Drug Interactions

Thank you

Trial Information

Phase I Clinical Trial to Evaluate the Efficacy of Sulforaphane as an Antagonist to Human PXR-mediated Drug-drug Interactions

Inclusion Criteria:

- 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 Criteria:

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Outcome Measure:

Midazolam clearance (pharmacokinetic measure of Cytochrome P450 3A4 activity)

Outcome Time Frame:

7 days

Safety Issue:


Principal Investigator

David L Eaton, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington


United States: Institutional Review Board

Study ID:




Start Date:

March 2008

Completion Date:

September 2010

Related Keywords:

  • Adverse Drug Interactions
  • drug interactions
  • cytochrome P4503A4
  • Pregnane X-receptor
  • induction
  • drug metabolism



Fred Hutchinson Cancer Research Center Seattle, Washington  98109
UW General Clinical Research Center Seattle, Washington  98105