Comparative Multidose Pharmacokinetics
Conditions
Keywords
Pharmacokinetics, Dietary Supplements, Curcumin
Brief summary
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.
Interventions
DRUGcurcumin
standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. 18 - 65 years of age 2. BMI 18 - 30 kg/m\^2 3. Ability/willing to provide informed consent 4. Good general health
Exclusion criteria
1. History of any pancreatic or biliary disease (eg. Familial colorectal cancer syndromes, Ulcerative colitis or Crohn's disease) 2. History of any acute or chronic illness that requires current medical therapy, including active gastrointestinal conditions, that might interfere with drug absorption 3. History of large bowel resection for any reason 4. Diagnosed narcotic or alcohol dependence 5. Women with childbearing potential who do not agree to practice effective birth control. 6. Use of curcumin within the last 14 days 7. Allergy to study agent 8. Individuals with creatinine, AST or ALT above 1.5 times the upper limit of normal at baseline. 9. Personal or inherited bleeding disorders or therapeutic anti-coagulation with warfarin. 10. Women who are pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC | 0-48h | Area under plasma concentration curve from 0-48h using 13 time points. |
| Cmax | 0-48h | Maximum curcumin plasma concentration |
| Tmax | 0-48h | Time to maximum curcumin plasma concentration |
| Ke | 0-48h | Terminal elimination rate |
| T1/2 | 0-48h | plasma curcumin concentration half-life |
| Vd | 0-48h | Volume of distribution |
| Test of bioequivalence | 0-48h | geometric mean ratio of plasma AUC0-48h of the two formulations |
| bioequivalence of tissue curcumin concentration | 1h | comparison of curcumin concentration in colorectal tissue at single time point between two formulations |
Countries
United States
Outcome results
None listed