TA-65 Pharmacokinetic Study



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:22 - 55
Updated:5/11/2018
Start Date:September 2016
End Date:February 2017

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A Pharmacokinetic And Relative Bioavailability Of Different Formulation Of Nutritional Supplement TA-65 In Healthy Volunteers: A Pilot, Replicate Cross-Over Study

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.

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.

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
We found this trial at
1
site
New York, New York 10016
Principal Investigator: David Keefe, MD
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mi
from
New York, NY
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