Clinical trial NCT01330810: Curcumin Pharmacokinetics
Official title: Crossover, Multiple Dose Pharmacokinetics of Two Curcumin Formulations in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Comparative Multidose Pharmacokinetics
Keywords: Pharmacokinetics
Dietary Supplements
Curcumin
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2011-04-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: AUC
timeFrame: 0-48h
measure: Cmax
timeFrame: 0-48h
measure: Tmax
timeFrame: 0-48h
measure: Ke
timeFrame: 0-48h
measure: T1/2
timeFrame: 0-48h
measure: Vd
timeFrame: 0-48h
measure: Test of bioequivalence
timeFrame: 0-48h
measure: bioequivalence of tissue curcumin concentration
timeFrame: 1h
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Department of Family Medicine
state: North Carolina
Study officials:
affiliation: UNC
name: Gary N Asher, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Asher GN, Xie Y, Moaddel R, Sanghvi M, Dossou KS, Kashuba AD, Sandler RS, Hawke RL. Randomized Pharmacokinetic Crossover Study Comparing 2 Curcumin Preparations in Plasma and Rectal Tissue of Healthy Human Volunteers. J Clin Pharmacol. 2017 Feb;57(2):185-193. doi: 10.1002/jcph.806. Epub 2016 Sep 6.