Curcumin Pharmacokinetics

Phase 1

Completed

• Conditions: Comparative Multidose Pharmacokinetics
• Interventions: Drug: curcumin

• Registration Number: NCT01330810
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-07
• Status Verified: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2012-04
• Last Update Submitted: 2017-08-02
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C3 tablet	curcumin	4g C3 tablet
Meriva	curcumin	2g Meriva powder

Primary Outcome Measures

Name	Time	Method
Tmax	0-48h	Time to maximum curcumin plasma concentration
Cmax	0-48h	Maximum curcumin plasma concentration
AUC	0-48h	Area under plasma concentration curve from 0-48h using 13 time points.
Ke	0-48h	Terminal elimination rate
T1/2	0-48h	plasma curcumin concentration half-life
Test of bioequivalence	0-48h	geometric mean ratio of plasma AUC0-48h of the two formulations
Vd	0-48h	Volume of distribution
bioequivalence of tissue curcumin concentration	1h	comparison of curcumin concentration in colorectal tissue at single time point between two formulations

Trial Locations

Locations (1)

UNC Department of Family Medicine; 🇺🇸 Chapel Hill, North Carolina, United States