HealthyPhase 1NCT02731807
TA-65 Pharmacokinetic Study
A Phase 1 study testing Dose A: TA-65 24mg, powder, Dose B: TA-65, 8mg, powder and Dose C: TA-65 3.2mg, capsule in people with Healthy, run by NYU Langone Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dose A: TA-65 24mg, powder, Dose B: TA-65, 8mg, powder and Dose C: TA-65 3.2mg, capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Feb 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Medical Center
New York, New York, 10016
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- 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
- Keywords
- TA-65, Telemorase, Dietary Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose A: TA-65 24mg, powderDietary supplement
Also called CAG
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, capsuleDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Dose A, B, C, D, E | Experimental | All participants will receive all doses throughout the course of the study. Receives: 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 |
| Dose D, E, C, B, A | Experimental | All participants will receive all doses throughout the course of the study. Receives: 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 |
| Dose C, D, E, A, B | Experimental | All participants will receive all doses throughout the course of the study. Receives: 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 |
| Dose E, D, C, B, A | Experimental | All participants will receive all doses throughout the course of the study. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration (c max) of TA-65 in serum
Measured: 12 hours
Time to reach maximum concentration (T max) of TA-65 in serum
Measured: 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.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Keefe, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731807
- Sponsor's protocol ID
- 15-00834
- Status last verified
- May 2018
- First submitted
- 4 Apr 2016
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic And Relative Bioavailability Of Different Formulation Of Nutritional Supplement TA-65 In Healthy Volunteers: A Pilot, Replicate Cross-Over Study
- ClinicalTrials.gov ID
- NCT02731807
- Acronym / sponsor ID
- 15-00834
- Conditions
- Healthy
- Keywords
- TA-65, Telemorase, Dietary Supplement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose A, B, C, D, E | Experimental | 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, capsuleAll participants will receive all doses throughout the course of the study. |
| Dose D, E, C, B, A | Experimental | 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, capsuleAll participants will receive all doses throughout the course of the study. |
| Dose C, D, E, A, B | Experimental | 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, capsuleAll participants will receive all doses throughout the course of the study. |
| Dose E, D, C, B, A | Experimental | 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, capsuleAll participants will receive all doses throughout the course of the study. |
Who may qualify
- Ages
- 22 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose A: TA-65 24mg, powderAlso: CAG | Dietary supplement | Dose A, B, C, D, E, Dose C, D, E, A, B, Dose D, E, C, B, A, Dose E, D, C, B, A |
| Dose B: TA-65, 8mg, powder | Dietary supplement | Dose A, B, C, D, E, Dose C, D, E, A, B, Dose D, E, C, B, A, Dose E, D, C, B, A |
| Dose C: TA-65 3.2mg, capsule | Dietary supplement | Dose A, B, C, D, E, Dose C, D, E, A, B, Dose D, E, C, B, A, Dose E, D, C, B, A |
| Dose D: TA-65 8mg, capsule | Dietary supplement | Dose A, B, C, D, E, Dose C, D, E, A, B, Dose D, E, C, B, A, Dose E, D, C, B, A |
| Dose E: TA-65 32mg, capsule | Dietary supplement | Dose A, B, C, D, E, Dose C, D, E, A, B, Dose D, E, C, B, A, Dose E, D, C, B, A |
Primary outcome
Maximum Concentration (c max) of TA-65 in serum
Time frame: 12 hours
Time to reach maximum concentration (T max) of TA-65 in serum
Time frame: 12 hours
Area Under the Curve (AUC)
Time frame: 12 hours
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Keefe, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dose A: TA-65 24mg, powder, Dose B: TA-65, 8mg, powder and Dose C: TA-65 3.2mg, capsule in people with Healthy, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Concentration (c max) of TA-65 in serum (time frame: 12 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.