Curcumin Pharmacokinetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01330810
First received: April 4, 2011
Last updated: February 6, 2013
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Comparative Multidose Pharmacokinetics
Drug: curcumin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Crossover, Multiple Dose Pharmacokinetics of Two Curcumin Formulations in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • AUC [ Time Frame: 0-48h ] [ Designated as safety issue: No ]
    Area under plasma concentration curve from 0-48h using 13 time points.

  • Cmax [ Time Frame: 0-48h ] [ Designated as safety issue: No ]
    Maximum curcumin plasma concentration

  • Tmax [ Time Frame: 0-48h ] [ Designated as safety issue: No ]
    Time to maximum curcumin plasma concentration

  • Ke [ Time Frame: 0-48h ] [ Designated as safety issue: No ]
    Terminal elimination rate

  • T1/2 [ Time Frame: 0-48h ] [ Designated as safety issue: No ]
    plasma curcumin concentration half-life

  • Vd [ Time Frame: 0-48h ] [ Designated as safety issue: No ]
    Volume of distribution

  • Test of bioequivalence [ Time Frame: 0-48h ] [ Designated as safety issue: No ]
    geometric mean ratio of plasma AUC0-48h of the two formulations

  • bioequivalence of tissue curcumin concentration [ Time Frame: 1h ] [ Designated as safety issue: No ]
    comparison of curcumin concentration in colorectal tissue at single time point between two formulations


Enrollment: 12
Study Start Date: March 2011
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330810

Locations
United States, North Carolina
UNC Department of Family Medicine
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Gary N Asher, MD, MPH UNC
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01330810     History of Changes
Other Study ID Numbers: 10-2243
Study First Received: April 4, 2011
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Pharmacokinetics
Dietary Supplements
Curcumin

Additional relevant MeSH terms:
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014