TA-65 Pharmacokinetic Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Dose A: TA-65 24mg, powder; Dose B: TA-65, 8mg, powder; Dose C: TA-65 3.2mg, capsule; Dose D: TA-65 8mg, capsule; Dose E: TA-65 32mg, capsule
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Other intervention name(s): CAG
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: TA-65; Telemorase; Dietary Supplement