A Study of the Pharmacokinetics of Three Dosages of Niagen in Healthy Subjects

Pharmacokinetics Clinical Trial

— 14NBHC  

Official title:

A Randomized, Double-blind, Cross-over Study of the Pharmacokinetics of Three Dosages of Niagen in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191462
• Other study ID #: 14NBHC
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2014
• Last updated: September 8, 2014
• Start date: July 2014
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: KGK Synergize Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study in to analyse the way in which the body processes Niagen (nicotinamide riboside) in healthy people. Blood and urine samples from subjects who are given a dose of Niagen will be analyzed for metabolites over the 24 hours after taking the dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy Male or female age 30-55 years

• BMI 18.5-29.9 kg/m2

• If female, subject is not of child bearing potential, OR Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.

• Healthy as determined by laboratory results and medical history

• Agrees to maintain current level of physical activity throughout the study

• Agrees to avoid vitamins and St. John's Wort for 30 days prior to enrollment and during the study

• Agrees to avoid nutritional yeast, whey proteins, energy drinks, dairy products, grapefruit and grapefruit juice and alcohol 7 days prior to enrollment and during study

• Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial.

• Use of natural health products (NHPs)/dietary supplements within 7 days prior to randomization and during the course of the study.

• Use of vitamins or St. John's Wort in the last 30 days before the study enrollment,

• Use of natural health products containing Nicotinamide riboside within 7 days prior to randomization and during the course of the study

• Use of nutritional yeast, whey proteins, energy drinks, grapefruit and grapefruit juice, dairy products, alcohol for 7 days prior to the study

• Subjects who are smokers

• Subjects with blood pressure =140/90

• Use of blood pressure medications

• Use of cholesterol lowering medications

• Metabolic diseases or chronic diseases

• Use of acute over the counter medication within 72 hours of test product dosing

• Unstable medical conditions as determined by the Qualified Investigator

• 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 Medical 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 after diagnosis are acceptable

• History of blood/bleeding disorders

• Blood donation in the past 2 months

• Alcohol abuse (>2 standard alcoholic drinks per day) or drug abuse within the past 6 months

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Dietary Supplement:
• Niagen 100mg

• Niagen 300mg

• Niagen 1000mg

Locations

Country	Name	City	State
Canada	KGK Synergize Inc.	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
KGK Synergize Inc.	ChromaDex, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Area under the curve (AUC(0-24h)	24 hour dosing period; 3 dosing periods each separated by 7 day washout	24 hours	No
Other	AUCI (AUC to infinity)	24 hour dosing period; 3 dosing periods each separated by 7 day washout	24 hours	No
Other	AUC(0-24h)/AUCI	24 hour dosing period; 3 dosing periods each separated by 7 day washout	24 hours	No
Other	Maximum observed concentration (Cmax)	24 hour dosing period; 3 dosing periods each separated by 7 day washout	24 hours	No
Other	Time of maximum concentration (Tmax),	24 hour dosing period; 3 dosing periods each separated by 7 day washout	24 hours	No
Other	? (terminal disposition rate constant)	24 hour dosing period; 3 dosing periods each separated by 7 day washout	24 hours	No
Other	AUCReftmax (Area under the curve to tmax)	24 hour dosing period; 3 dosing periods each separated by 7 day washout	24 hours	No
Other	Blood Safety parameters	CBC	24 hour dosing period; pre dose and 24 hr post dose	Yes
Other	Blood Safety parameters	electrolytes	24 hour dosing period; pre dose and 24 hr post dose	Yes
Other	Blood Safety parameters	glucose	24 hour dosing period; pre dose and 24 hr post dose	Yes
Other	Blood Safety parameters	creatinine	24 hour dosing period; pre dose and 24 hr post dose	Yes
Other	Blood Safety parameters	AST	24 hour dosing period; pre dose and 24 hr post dose	Yes
Other	Blood Safety parameters	ALT	24 hour dosing period; pre dose and 24 hr post dose	Yes
Other	Blood Safety parameters	GGT	24 hour dosing period; pre dose and 24 hr post dose	Yes
Other	Blood Safety parameters	uric acid	24 hour dosing period; pre dose and 24 hr post dose	Yes
Other	Blood Safety parameters	bilirubin	24 hour dosing period; pre dose and 24 hr post dose	Yes
Other	Vital Signs	Heart Rate	24 hour period: pre-dose, 1h, 4h, 6h, 12h, 24h post-dose	Yes
Other	Vital Signs	Blood Pressure	24 hour period: pre-dose, 1h, 4h, 6h, 12h, 24h post-dose	Yes
Primary	t1/2 (terminal half-life)	24 hour dosing period; 3 dosing periods each separated by 7 day washout	24 hours	No