Clinical trial NCT02731807: TA-65 Pharmacokinetic Study
Official title: A Pharmacokinetic And Relative Bioavailability Of Different Formulation Of Nutritional Supplement TA-65 In Healthy Volunteers: A Pilot, Replicate Cross-Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: TA-65
Telemorase
Dietary Supplement
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-08
Enrollment: 8
Sex: ALL
Minimum age (years): 22
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study is a pilot research study in humans to determine the steady state pharmacokinetic profile of TA-65 after oral dose of formulated and unformulated forms. There will be eight (8) subjects of healthy men and women (non-child bearing). TA-65 is supposed to supplement the diet to increase general health through telomerase activation.The active ingredient in TA-65 activates an enzyme called telomerase. However, the active ingredient has poor oral bioavailability in humans. This study is created to enhance the bioavailability in telomerase with different formulations; powder and capsule form.

Detailed description: This is an open labeled, replicate cross-over study with eight (8) subjects which will include men and women (non childbearing age) and be completed over a period of six (6) weeks. The supplement TA-65 will be given to subjects in both capsules and powder form.

TA-65 is a dietary supplement. The active ingredient is isolated from roots of Astragalus species. The active ingredient has been proven to activate an enzyme called telomerase. TA-65 in intended to supplement the diet to increase the general health through telomerase activation. The active ingredient has poor oral bioavailability in humans. The current study is aimed at assessing the bioavailability of the active ingredient with different formulations designed to enhance the bioavailability.

The objective of the study is to determine the steady state pharmacokinetic profile of TA-65 following oral dose of formulated (powder and capsules) and unformulated (powder) forms as assessed by Cmax, Tmax and AUC (area under the curve).

This will be a pilot, open-label, replicate cross-over study to evaluate the pharmacokinetic profile of active ingredient in eight subjects following the oral intake of TA-65 varying in formulations and doses. The subjects are expected to participate in this study for a period of 28 days. After initial screening, all subjects will visit the study center on five different days (day 1, day 7, day 14, day 21 and day 28). During each visit, all eight subjects will orally take one of the five test materials.

The washout period is seven days during which all subjects refrain from taking TA-65 in any form.

Pharmacokinetic sampling for measurement of plasma concentrations will be conducted over a 12 hour period following the oral dose. Blood will be withdrawn from all subjects prior to the intake of the test materials (0 hr.) and 1, 2, 3, 4, 5, 7, 10 and 12 hours following the oral intake of the test material. Serum will be separated from each blood sample and stored at -20° C. The amount of TA-65 in each serum samples will be analyzed by mass spectrometry.

Eligibility criteria: Inclusion Criteria:

* Healthy adult male or non-childbearing potential females, 22-55 years of age
* Subjects who have signed a written informed consent consistent.
* BMI ≥ 18.5 and ≤ 32.0 at screening with a maximum weight of 120 kg
* Medically healthy and good health as deemed by PI
* Subjects who are not on any medication or dietary supplement.
* Subjects who are able to follow the protocol as designed by TA Science and NYU

Exclusion Criteria:

* History of serious medical condition or psychiatric condition
* Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit
* Recent history of myocardial infarction.
* Subjects with a history of cancer within the last 5 years.
* Subjects currently taking any prescribed medications or any OTC (over-the-counter) dietary supplements.
* History of drug or alcohol addiction.
* Females who are pregnant, lactating, or nursing or who may become pregnant during the course of the study.
* Patients diagnosed as HIV-positive, diagnosed with AIDS.
* Clinically significant infection within 3 months prior to screening as determined by the PI
* Consumption of grapefruit or grapefruit juice within seven days prior to the first dose of study medication and throughout the pharmacokinetic phase of the study.
* Patients with any condition not previously named that, in the opinion of the investigators or intake staff, would jeopardize the safety of the patient or affect the validity of the data collected in this study.
* Has donated blood within 3 months of screening visit or plans to donate blood within 3 months of study completion.
* Plasma donation within 7 days prior to dosing of test product
* Participation in another clinical trial within 30 days prior to screening.
* Allergy to heparin

Primary outcomes:
measure: Maximum Concentration (c max) of TA-65 in serum
timeFrame: 12 hours
measure: Time to reach maximum concentration (T max) of TA-65 in serum
timeFrame: 12 hours
measure: Area Under the Curve (AUC)
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: David Keefe, MD
role: PRINCIPAL_INVESTIGATOR
References: