Curcumin Pharmacokinetics

NCT ID: NCT01330810

Last Updated: 2017-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-04-30

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.

Conditions

Comparative Multidose Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

C3 tablet

4g C3 tablet

Group Type: ACTIVE_COMPARATOR

curcumin

Intervention Type: DRUG

standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin

Meriva

2g Meriva powder

Group Type: ACTIVE_COMPARATOR

curcumin

Intervention Type: DRUG

standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin

Interventions

curcumin

standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary N Asher, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UNC

Locations

UNC Department of Family Medicine

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27503249 (View on PubMed)

Other Identifiers

10-2243

Identifier Type: -

Identifier Source: org_study_id