drugset / Trial / NCT01330810

Curcumin Pharmacokinetics

NCT01330810

Phase 1 Completed 12 enrolled University of North Carolina, Chapel Hill
RandomizedCrossoverQuadruple-blindOther

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.

Timeline

Start
2011-03
Primary completion
2011-12
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Curcumin Small molecule 2 g Oral
Comparator Curcumin Small molecule 4 g Oral

Indications

No indication recorded.