NCT02731807

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2016

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

April 4, 2016

Last Update Submit

May 8, 2018

Conditions

Healthy

Keywords

TA-65TelemoraseDietary Supplement

Outcome Measures

Primary Outcomes (3)

  • Maximum Concentration (c max) of TA-65 in serum

    12 hours

  • Time to reach maximum concentration (T max) of TA-65 in serum

    12 hours

  • Area Under the Curve (AUC)

    For a given time interval (t2-t1), the AUC is calculated as follows: AUC =1/2 (C1+C2)(t2-t1) Where the C1 and C2 are the amount of the test product in blood at time 1 (t1) and time 2 (t2) respectively. Average concentration of test material in the body over the total time interval will be calculate by the sum of all of the intervals together from the first time point to the last.

    12 hours

Study Arms (4)

Dose A, B, C, D, E

EXPERIMENTAL

All participants will receive all doses throughout the course of the study.

Dietary Supplement: Dose A: TA-65 24mg, powderDietary Supplement: Dose B: TA-65, 8mg, powderDietary Supplement: Dose C: TA-65 3.2mg, capsuleDietary Supplement: Dose D: TA-65 8mg, capsuleDietary Supplement: Dose E: TA-65 32mg, capsule

Dose D, E, C, B, A

EXPERIMENTAL

All participants will receive all doses throughout the course of the study.

Dietary Supplement: Dose A: TA-65 24mg, powderDietary Supplement: Dose B: TA-65, 8mg, powderDietary Supplement: Dose C: TA-65 3.2mg, capsuleDietary Supplement: Dose D: TA-65 8mg, capsuleDietary Supplement: Dose E: TA-65 32mg, capsule

Dose C, D, E, A, B

EXPERIMENTAL

All participants will receive all doses throughout the course of the study.

Dietary Supplement: Dose A: TA-65 24mg, powderDietary Supplement: Dose B: TA-65, 8mg, powderDietary Supplement: Dose C: TA-65 3.2mg, capsuleDietary Supplement: Dose D: TA-65 8mg, capsuleDietary Supplement: Dose E: TA-65 32mg, capsule

Dose E, D, C, B, A

EXPERIMENTAL

All participants will receive all doses throughout the course of the study.

Dietary Supplement: Dose A: TA-65 24mg, powderDietary Supplement: Dose B: TA-65, 8mg, powderDietary Supplement: Dose C: TA-65 3.2mg, capsuleDietary Supplement: Dose D: TA-65 8mg, capsuleDietary Supplement: Dose E: TA-65 32mg, capsule

Interventions

Dose A: TA-65 24mg, powderDIETARY_SUPPLEMENT
Also known as: CAG
Dose A, B, C, D, EDose C, D, E, A, BDose D, E, C, B, ADose E, D, C, B, A
Dose B: TA-65, 8mg, powderDIETARY_SUPPLEMENT
Dose A, B, C, D, EDose C, D, E, A, BDose D, E, C, B, ADose E, D, C, B, A
Dose C: TA-65 3.2mg, capsuleDIETARY_SUPPLEMENT
Dose A, B, C, D, EDose C, D, E, A, BDose D, E, C, B, ADose E, D, C, B, A
Dose D: TA-65 8mg, capsuleDIETARY_SUPPLEMENT
Dose A, B, C, D, EDose C, D, E, A, BDose D, E, C, B, ADose E, D, C, B, A
Dose E: TA-65 32mg, capsuleDIETARY_SUPPLEMENT
Dose A, B, C, D, EDose C, D, E, A, BDose D, E, C, B, ADose E, D, C, B, A

Eligibility Criteria

Age22 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Powders

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • David Keefe, MD

    NYU Langone Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 8, 2016

Study Start

September 1, 2016

Primary Completion

November 1, 2016

Study Completion

February 1, 2017

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations

US(1)