Completed

NCT Number: NCT01330810

Curcumin Pharmacokinetics

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.

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Key information

Conditions

Comparative Multidose Pharmacokinetics

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UNC Department of Family Medicine

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

curcumin

Drug

standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin

Primary outcomes

AUC

Time frame: 0-48h

Area under plasma concentration curve from 0-48h using 13 time points.
Cmax

Time frame: 0-48h

Maximum curcumin plasma concentration
Tmax

Time frame: 0-48h

Time to maximum curcumin plasma concentration
Ke

Time frame: 0-48h

Terminal elimination rate
T1/2

Time frame: 0-48h

plasma curcumin concentration half-life
Vd

Time frame: 0-48h

Volume of distribution
Test of bioequivalence

Time frame: 0-48h

geometric mean ratio of plasma AUC0-48h of the two formulations
bioequivalence of tissue curcumin concentration

Time frame: 1h

comparison of curcumin concentration in colorectal tissue at single time point between two formulations

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2012
First posted: Apr 7, 2011
Registry last updated: Aug 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.