Curcumin Pharmacokinetics

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

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.

Study Overview

• Status: Completed
• Conditions: Comparative Multidose Pharmacokinetics
• Intervention / Treatment: Drug: curcumin

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Department of Family Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: C3 tablet; 4g C3 tablet	Drug: curcumin; standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin
ACTIVE_COMPARATOR: Meriva; 2g Meriva powder	Drug: curcumin; standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: April 4, 2011
• First Submitted That Met QC Criteria: April 5, 2011
• First Posted (ESTIMATE): April 7, 2011

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Curcumin; Dietary Supplements
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: 10-2243