Comparative Multidose PharmacokineticsPhase 1NCT01330810
Curcumin Pharmacokinetics
A Phase 1 study testing curcumin in people with Comparative Multidose Pharmacokinetics, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Comparative Multidose Pharmacokinetics
- What is being tested?
- curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Apr 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 - 65 years of age
- BMI 18 - 30 kg/m^2
- Ability/willing to provide informed consent
- Good general health
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Department of Family Medicine
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
- Conditions
- Comparative Multidose Pharmacokinetics
- Being tested
- curcumin
- Keywords
- Pharmacokinetics, Dietary Supplements, Curcumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcuminDrug
standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin
| Study group | Role | What they receive |
|---|---|---|
| C3 tablet | Active comparator | 4g C3 tablet Receives: Drug: curcumin |
| Meriva | Active comparator | 2g Meriva powder Receives: Drug: curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Area under plasma concentration curve from 0-48h using 13 time points.
Measured: 0-48h
Cmax
Maximum curcumin plasma concentration
Measured: 0-48h
Tmax
Time to maximum curcumin plasma concentration
Measured: 0-48h
Ke
Terminal elimination rate
Measured: 0-48h
T1/2
plasma curcumin concentration half-life
Measured: 0-48h
Vd
Volume of distribution
Measured: 0-48h
Test of bioequivalence
geometric mean ratio of plasma AUC0-48h of the two formulations
Measured: 0-48h
bioequivalence of tissue curcumin concentration
comparison of curcumin concentration in colorectal tissue at single time point between two formulations
Measured: 1h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Comparative Multidose PharmacokineticsStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary N Asher, MD, MPH, Principal investigator, UNC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330810
- Sponsor's protocol ID
- 10-2243
- Status last verified
- Dec 2011
- First submitted
- 4 Apr 2011
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27503249
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossover, Multiple Dose Pharmacokinetics of Two Curcumin Formulations in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01330810
- Acronym / sponsor ID
- 10-2243
- Conditions
- Comparative Multidose Pharmacokinetics
- Keywords
- Pharmacokinetics, Dietary Supplements, Curcumin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 7 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C3 tablet | Active comparator | Drug: curcumin4g C3 tablet |
| Meriva | Active comparator | Drug: curcumin2g Meriva powder |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 - 65 years of age
- BMI 18 - 30 kg/m^2
- Ability/willing to provide informed consent
- Good general health
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| curcuminstandardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin | Drug | C3 tablet, Meriva |
Primary outcome
AUC
Time frame: 0-48h
Area under plasma concentration curve from 0-48h using 13 time points.
Cmax
Time frame: 0-48h
Maximum curcumin plasma concentration
Tmax
Time frame: 0-48h
Time to maximum curcumin plasma concentration
Ke
Time frame: 0-48h
Terminal elimination rate
T1/2
Time frame: 0-48h
plasma curcumin concentration half-life
Vd
Time frame: 0-48h
Volume of distribution
Test of bioequivalence
Time frame: 0-48h
geometric mean ratio of plasma AUC0-48h of the two formulations
bioequivalence of tissue curcumin concentration
Time frame: 1h
comparison of curcumin concentration in colorectal tissue at single time point between two formulations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
- Results publication: PubMed 27503249Asher 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary N Asher, MD, MPH principal investigator
UNC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing curcumin in people with Comparative Multidose Pharmacokinetics, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (time frame: 0-48h). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01330810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.