Curcumin Pharmacokinetics

Completed · Phase 1

Conditions studied: Comparative Multidose Pharmacokinetics

In brief

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.

Key facts

Study ID

NCT01330810

Run by

University of North Carolina, Chapel Hill

People needed

12

Starts

2011-03-01

Expected to finish

2012-04-01

Last updated by the study team

2017-08-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 - 65 years of age
• BMI 18 - 30 kg/m\^2
• Ability/willing to provide informed consent
• Good general health

You may not qualify if…

• 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.

Where it is running

• UNC Department of Family Medicine — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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