TA-65 Pharmacokinetic Study

NCT02731807 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-05-09

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Dose A: TA-65 24mg, powder

DIETARY_SUPPLEMENT

Dose B: TA-65, 8mg, powder

DIETARY_SUPPLEMENT

Dose C: TA-65 3.2mg, capsule

DIETARY_SUPPLEMENT

Dose D: TA-65 8mg, capsule

DIETARY_SUPPLEMENT

Dose E: TA-65 32mg, capsule

Sponsors & Collaborators

Principal Investigators

  • David Keefe, MD · NYU Langone Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
22 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2016-11-30
Completion
2017-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02731807 on ClinicalTrials.gov