Healthy Subjects Needed for a Botanical-Drug Interaction Study
This study will help identify how the effects of individual genetic variations and concurrent drug intake with the herbal product curcumin impacts a specific protein primarily found in the intestine.
The study comprises two parts. In Part 1, a blood sample will be obtained for genetic testing to determine your eligibility for Part 2. Part 2 consists of two study arms, Arm 1 and Arm 2, which are contingent upon your genetic results. Participation in one or both study arms of Part 2 may be requested. In Part 2 Arm 1, the drug diclofenac will be administered alone, while in Part 2 Arm 2, diclofenac will be administered in combination with the herbal product curcumin. Following diclofenac/curcumin administration, blood will be drawn through an intravenous line, and stool and urine samples will also be collected. A screening medical examination will be provided, along with routine blood and urine laboratory tests.
You will receive
- up to $50 for completing only Part 1 (2 hours)
- up to $250 for completing only Part 2 Arm 1 (12 hours)
- up to $450 for completing both Parts 2 Arm 2 (12 hours)
You may be eligible to take part in this study if you
- Are aged from 18-64 years and healthy
- Are not taking any medications (prescription and non-prescription) or dietary/herbal supplements known to alter the pharmacokinetics of diclofenac or curcumin
- Are willing to abstain from consuming caffeinated beverages or other caffeine-containing products the evening before and morning of the first day of each study day
- Are willing to abstain from consuming any alcoholic beverages for one day prior to any study day during the 14-hour inpatient days
- Are willing to use a secondary method of birth control that does not include the introduction or discontinuance of hormonal-based birth control (such as abstinence, copper IUD, or condoms)
- Have the time to participate
- Can provide written informed consent and have the ability to comply with the requirements of the study
You will not be eligible to take part in this study if you
- Are under the age of 18 or over the age of 65 years
- Smoke/vape/chew tobacco products
- Use cannabis products, including marijuana, hemp, and other THC- or CBD-containing products
- Have any current major illness or chronic illness such as (but not limited to) kidney disease, hepatic disease, diabetes mellitus, hypertension, coronary artery disease, chronic obstructive pulmonary disease, cancer, or HIV/AIDS
- Have a history of anemia or any other significant hematologic disorder
- Have a history of drug or alcohol addiction or major psychiatric illness
- Are pregnant or nursing or plan to become pregnant within 3 weeks after participation
- Have a history of allergy intolerance to diclofenac or curcumin
- Are taking concomitant medications, both prescription and non-prescription (including dietary supplements/herbal products), known to alter the pharmacokinetics of diclofenac or curcumin
- Are taking any turmeric spice or curcumin supplement
- Have a condition or abnormality that, in the opinion of the Investigator, would compromise participant safety or quality of the data
- Have an out-of-range clinical laboratory value that is considered a health risk for participating in the study
The Washington State University College of Pharmacy and Pharmaceutical Sciences is conducting this research study through funding provided by the National Institutes of Health.
For more information about this study, please contact:
Deena Hadi, Program Manager
Phone: (509) 368-6692
Email: deena.hadi@wsu.edu
Siavosh Naji-Talakar, PharmD
Phone: (509) 358-7739
Email: s.naji-talakar@wsu.edu
The WSU Institutional Review Board has reviewed and approved this research project for human subject participation.
