NCT01330810

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 7, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

August 3, 2017

Status Verified

December 1, 2011

Enrollment Period

9 months

First QC Date

April 4, 2011

Last Update Submit

August 2, 2017

Conditions

Comparative Multidose Pharmacokinetics

Keywords

PharmacokineticsDietary SupplementsCurcumin

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (2)

C3 tablet

ACTIVE COMPARATOR

4g C3 tablet

Drug: curcumin

Meriva

ACTIVE COMPARATOR

2g Meriva powder

Drug: curcumin

Interventions

curcuminDRUG

standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin

C3 tabletMeriva

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • BMI 18 - 30 kg/m\^2
  • Ability/willing to provide informed consent
  • Good general health

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Department of Family Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • 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.

    PMID: 27503249RESULT

MeSH Terms

Interventions

Curcumin

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Gary N Asher, MD, MPH

    UNC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2011

First Posted

April 7, 2011

Study Start

March 1, 2011

Primary Completion

December 1, 2011

Study Completion

April 1, 2012

Last Updated

August 3, 2017

Record last verified: 2011-12

Locations

US(1)