A Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Forumulation to a Comparator Curcumin Product

NCT02474953 | Completed Phase 1

• 1 other identifier: 15PCHB
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Curcumin; Pharmacokinetic

Outcome Measures

Primary Outcomes (3)

• Curcumin AUC

  Area Under the Curve

  Time 0 to 48 hours

• Curcumin Cmax

  Maximum Concentration

  Time 0 to 48 hours

• Curcumin Tmax

  Time until maximum concentration

  Time 0 to 48 hours

Other Outcomes (8)

• Incidence of adverse events

  Time 0 to 48 hours

• Changes in blood CBC levels

  Time 0 to 48 hours

• Changes in blood electrolyte levels

  Time 0 to 48 hours

Study Arms (2)

Dosing Sequence 1

EXPERIMENTAL

Proprietary Curcumin Formulation administered first, Unformulated Comparator Curcumin Product administered second

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

Dietary Supplement: Proprietary Curcumin Formulation; Dietary Supplement: Unformulated Comparator Curcumin Product

Interventions

Proprietary Curcumin Formulation DIETARY_SUPPLEMENT

Dosing Sequence 1; Dosing Sequence 2

Unformulated Comparator Curcumin Product DIETARY_SUPPLEMENT

Dosing Sequence 1; Dosing Sequence 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• KGK Science Inc.: lead
• Boston Biopharm, Inc.: collaborator

Study Sites (1)

KGK Synergize Inc.

London, Ontario, N6A 5R8, Canada

Location

Study Officials

• Tetyana Pelipyagina, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 18, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

CA (1)