TA-65 Pharmacokinetic Study

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02731807

Run by

NYU Langone Health

People needed

8

Starts

2016-09-01

Expected to finish

2017-02-01

Last updated by the study team

2018-05-09

Who can join

Age: 22 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NYU Langone Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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