Curcumin Pharmacokinetics

Study Overview
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Brief Summary
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Each year, there are about 150,000 new colorectal cancer (CRC) cases and 50,000 CRC deaths in the United States. A safe and effective preventive agent could reduce the burden of colorectal cancer as well as reduce the costs associated with screening patients who are at high risk of developing CRC. Preclinical studies strongly suggest that curcumin is active against multiple pathways implicated in tumor initiation, progression, and metastasis. However, little is know how curcumin performs in humans. The investigators propose to enroll 12 healthy volunteers who will undergo blood draw and rectal biopsy after 7 days of curcumin administration. The investigators will look at curcumin preparations with low and high oral bioavailability and calculate the blood and rectal tissue concentrations associated with these two formulations to determine which preparation produces the highest tissue concentrations.

Official Title
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Crossover, Multiple Dose Pharmacokinetics of Two Curcumin Formulations in Healthy Volunteers

Conditions
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Comparative Multidose Pharmacokinetics

Intervention / Treatment
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* Drug: curcumin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 - 65 years of age BMI 18 - 30 kg/m^2 Ability/willing to provide informed consent Good general health Exclusion Criteria: History of any pancreatic or biliary disease (eg. Familial colorectal cancer syndromes, Ulcerative colitis or Crohn's disease) History of any acute or chronic illness that requires current medical therapy, including active gastrointestinal conditions, that might interfere with drug absorption History of large bowel resection for any reason Diagnosed narcotic or alcohol dependence Women with childbearing potential who do not agree to practice effective birth control. Use of curcumin within the last 14 days Allergy to study agent Individuals with creatinine, AST or ALT above 1.5 times the upper limit of normal at baseline. Personal or inherited bleeding disorders or therapeutic anti-coagulation with warfarin. Women who are pregnant or nursing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: C3 tablet<br>4g C3 tablet | Drug: curcumin<br>* standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin<br>|
| Active Comparator: Meriva<br>2g Meriva powder | Drug: curcumin<br>* standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC | Area under plasma concentration curve from 0-48h using 13 time points. | 0-48h | 
| Cmax | Maximum curcumin plasma concentration | 0-48h | 
| Tmax | Time to maximum curcumin plasma concentration | 0-48h | 
| Ke | Terminal elimination rate | 0-48h | 
| T1/2 | plasma curcumin concentration half-life | 0-48h | 
| Vd | Volume of distribution | 0-48h | 
| Test of bioequivalence | geometric mean ratio of plasma AUC0-48h of the two formulations | 0-48h | 
| bioequivalence of tissue curcumin concentration | comparison of curcumin concentration in colorectal tissue at single time point between two formulations | 1h | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Dietary Supplements, Curcumin