HealthyPhase 115PCHBNCT02474953
A Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Forumulation to a Comparator Curcumin Product
A Phase 1 study testing Proprietary Curcumin Formulation and Unformulated Comparator Curcumin Product in people with Healthy, run by KGK Science Inc. at 1 site in Canada.
Trial summary
This study is investigating the pharmacokinetic profile (i.e. the way the product is processed by the body) of a proprietary curcumin formulation compared to an unformulated curcumin product. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Proprietary Curcumin Formulation and Unformulated Comparator Curcumin Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to Jun 2015
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and females 18-45 years of age
- If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR
- Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Non-hormonal intrauterine devices
Show all 16Show fewer
- Vasectomy of partner
- BMI 18-29.9 kg/m2 (±1 kg/m2)
- Healthy as determined by laboratory results and medical history
- Agrees to maintain current level of physical activity throughout the study
- Agree to avoid using black or white pepper, turmeric, curcumin or curry in the preparation of food for 7 days prior to randomization and throughout the study period.
- Agree to avoid Indian and Thai cuisines for the period of the study
- Agree to avoid food with yellow dye #E100
- Agrees to avoid alcohol, caffeine 12 hours and grapefruit and grapefruit juice 48 hours prior to baseline and each subsequent clinic visit
- Agrees to consume only low polyphenols in the diet (nutritionists will counsel on high polyphenol fruits, vegetables to avoid, wine, beer, supplements, herbal extracts, and whole-grain based foods) 3 days prior to baseline and on test days (meal options and lists of foods to avoid will be provided to subjects by nutritionists)
- Has given voluntary, written, informed consent to participate in the study
Who cannot join
- BMI ≥ 30 kg/m2
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
- Unstable medical conditions as determined by the Qualified Investigator
- Use of natural health products containing turmeric or curcumin within 7 days prior to randomization and during the course of the study
- Use of St Johns Wort 3 weeks prior to baseline and during the study
- Subjects who are smokers
Show all 25Show fewer
- Subjects with current or history of gastrointestinal problems or disease
- Metabolic, endocrine, or chronic diseases
- Immunocompromised individuals such as subjects that have undergone organ transplantation or subjects diagnosed with human immunodeficiency virus (HIV)
- Clinically significant abnormal lab results at screening (e.g. AST and/or ALT > 2 x ULN, and/or bilirubin > 2 x ULN) will be assessed by the Qualified Investigator
- Subjects who have planned surgery during the course of the trial
- History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years of diagnosis are acceptable.
- History of gallbladder issues, hyperacidity, gastric/duodenal ulcers.
- Prior use of prescription H2 blocker, proton pump inhibitor or blood sugar-lowering agents
- Use of blood pressure medication
- Subjects on restrictive dietary regimens
- Blood donation in the last 2 months
- History of blood/bleeding disorders or taking prescription blood thinners or anti-platelet therapy
- Alcohol abuse (>2 standard alcoholic drinks per day) or drug abuse within the past 6 months
- Use of medical marijuana
- Clinically significant abnormal laboratory results at screening
- Participation in a clinical research trial within 30 days prior to randomization
- Allergy or sensitivity to study supplement ingredients or to any food or beverage provided during the study
- Individuals who are cognitively impaired and/or who are unable to give informed consent
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Crossover Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Formulation to a Comparator Curcumin Product
This study is investigating the pharmacokinetic profile (i.e. the way the product is processed by the body) of a proprietary curcumin formulation compared to an unformulated curcumin product. Subjects will take a single dose of either the proprietary formulation or comparator product and the blood levels of curcumin and curcumin metabolites will be measured over a period of 48 hours.
- Conditions
- Healthy
- Being tested
- Proprietary Curcumin Formulation, Unformulated Comparator Curcumin Product
- Keywords
- Curcumin, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprietary Curcumin FormulationDietary supplement
Unformulated Comparator Curcumin ProductDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Dosing Sequence 1 | Experimental | Proprietary Curcumin Formulation administered first, Unformulated Comparator Curcumin Product administered second Receives: Dietary Supplement: Proprietary Curcumin Formulation; Dietary Supplement: Unformulated Comparator Curcumin Product |
| Dosing Sequence 2 | Experimental | Unformulated Comparator Curcumin Product administered first, Proprietary Curcumin Formulation administered second Receives: Dietary Supplement: Proprietary Curcumin Formulation; Dietary Supplement: Unformulated Comparator Curcumin Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Curcumin AUC
Area Under the Curve
Measured: Time 0 to 48 hours
Curcumin Cmax
Maximum Concentration
Measured: Time 0 to 48 hours
Curcumin Tmax
Time until maximum concentration
Measured: Time 0 to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Basic science
- 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
- KGK Science Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Biopharm, Inc.
- Responsible party
- Sponsor
- Investigators
- Tetyana Pelipyagina, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474953
- Sponsor's protocol ID
- 15PCHB
- Acronym
- 15PCHB
- Status last verified
- Sep 2015
- First submitted
- 10 Jun 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Crossover Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Formulation to a Comparator Curcumin Product
- ClinicalTrials.gov ID
- NCT02474953
- Acronym / sponsor ID
- 15PCHB / 15PCHB
- Conditions
- Healthy
- Keywords
- Curcumin, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- KGK Science Inc.Industry (pharma, biotech, devices)
- Collaborators
- Boston Biopharm, Inc.
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Jun 2015 (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.
This study is investigating the pharmacokinetic profile (i.e. the way the product is processed by the body) of a proprietary curcumin formulation compared to an unformulated curcumin product. Subjects will take a single dose of either the proprietary formulation or comparator product and the blood levels of curcumin and curcumin metabolites will be measured over a period of 48 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dosing Sequence 1 | Experimental | Dietary Supplement: Proprietary Curcumin Formulation, Dietary Supplement: Unformulated Comparator Curcumin ProductProprietary Curcumin Formulation administered first, Unformulated Comparator Curcumin Product administered second |
| Dosing Sequence 2 | Experimental | Dietary Supplement: Proprietary Curcumin Formulation, Dietary Supplement: Unformulated Comparator Curcumin ProductUnformulated Comparator Curcumin Product administered first, Proprietary Curcumin Formulation administered second |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Male and females 18-45 years of age
- If female, subject is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR
- Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
- BMI 18-29.9 kg/m2 (±1 kg/m2)
- Healthy as determined by laboratory results and medical history
Key exclusion criteria (25 listed)
- BMI ≥ 30 kg/m2
- Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
- Unstable medical conditions as determined by the Qualified Investigator
- Use of natural health products containing turmeric or curcumin within 7 days prior to randomization and during the course of the study
- Use of St Johns Wort 3 weeks prior to baseline and during the study
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 |
|---|---|---|
| Proprietary Curcumin Formulation | Dietary supplement | Dosing Sequence 1, Dosing Sequence 2 |
| Unformulated Comparator Curcumin Product | Dietary supplement | Dosing Sequence 1, Dosing Sequence 2 |
Primary outcome
Curcumin AUC
Time frame: Time 0 to 48 hours
Area Under the Curve
Curcumin Cmax
Time frame: Time 0 to 48 hours
Maximum Concentration
Curcumin Tmax
Time frame: Time 0 to 48 hours
Time until maximum concentration
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 23 Sep 2015.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Tetyana Pelipyagina, MD principal investigator
KGK Science Inc.
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 Proprietary Curcumin Formulation and Unformulated Comparator Curcumin Product in people with Healthy, run by KGK Science Inc. at 1 site in Canada.
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 16 inclusion and 25 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 23 Sep 2015. 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 Canada. 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?
Curcumin AUC (time frame: Time 0 to 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2015.