AgingNCT06550271
The Bioavailability of Compounded and Generic Rapamycin in Normative Aging Individuals
An observational study of Aging, run by AgelessRx at 1 site in United States.
Trial summary
This study collected real-world evidence to better understand and define the relative bioavailability ratio between compounded rapamycin and generic rapamycin, with a specific focus on relative efficacy in increasing rapamycin levels in the blood (blood rapamycin levels). Read more about this study
- Who is it for?
- Ages 40 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Rapamycin
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2023to 15 Dec 2023
- Phase
- Observational
- 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 40 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants who sought rapamycin prescription for longevity support, pain reduction, energy improvement, weight loss, mood improvement, sleep improvement, or oral health improvement were included in the study. To be eligible to receive AgelessRx's standard rapamycin treatment protocol, participants had to be ≥40 years of age, without a history of uncontrolled disease. All patients treated with rapamycin and opted for at least one blood draw test between May 1, 2023, and December 15, 2023, were included in this retrospective study.
Who may be able to join
- Receive AgelessRx's standard Rapamycin treatment protocol
- Opted to complete at least 1 blood draw at their local Quest Lab
Who cannot join
- Not approved for current AgelessRx standard Rapamycin treatment
- History of uncontrolled disease
- Unable to complete at least 1 blood draw at their local Quest Lab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Bioavailability of Compounded and Generic Rapamycin in Normative Aging Individuals: A Retrospective Study and Review With Clinical Implications
This study collected real-world evidence to better understand and define the relative bioavailability ratio between compounded rapamycin and generic rapamycin, with a specific focus on relative efficacy in increasing rapamycin levels in the blood (blood rapamycin levels).
- Conditions
- Aging
- Being tested
- Rapamycin
- Keywords
- Bioavailability, Rapamycin, Aging, Longevity, Sirolimus, Healthy aging, age-related conditions, energy improvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamycinDrug
Also called Sirolimus, Rapamune, Rapacan, Siromus
Rapamycin in 2 different dosage forms (compounded and generic)
| Study group | Role | What they receive |
|---|---|---|
| Compounded Rapamycin | Participants in this group were receiving Compounded Rapamycin (dosages include 5, 10, or 15mg) once per week Receives: Drug: Rapamycin | |
| Generic Rapamycin | Participants in this group were receiving Generia Rapamycin (dosages include 2,3,6, or 8mg) once per week Receives: Drug: Rapamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
define the relative bioavailability ratio between compounded rapamycin and generic rapamycin
define the relative bioavailability ratio between compounded rapamycin and generic rapamycin, with a specific focus on relative efficacy in increasing rapamycin levels in the blood (blood rapamycin levels).
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start25 Apr 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- AgelessRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sajad Zalzala, MD, Study director, AgelessRx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550271
- Sponsor's protocol ID
- ALRx005
- Status last verified
- Aug 2024
- First submitted
- 9 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bioavailability of Compounded and Generic Rapamycin in Normative Aging Individuals: A Retrospective Study and Review With Clinical Implications
- ClinicalTrials.gov ID
- NCT06550271
- Acronym / sponsor ID
- ALRx005
- Conditions
- Aging
- Keywords
- Bioavailability, Rapamycin, Aging, Longevity, Sirolimus, Healthy aging, age-related conditions, energy improvement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- AgelessRxIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 13 Aug 2024 (actual)
- 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 collected real-world evidence to better understand and define the relative bioavailability ratio between compounded rapamycin and generic rapamycin, with a specific focus on relative efficacy in increasing rapamycin levels in the blood (blood rapamycin levels).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compounded Rapamycin | – | Drug: RapamycinParticipants in this group were receiving Compounded Rapamycin (dosages include 5, 10, or 15mg) once per week |
| Generic Rapamycin | – | Drug: RapamycinParticipants in this group were receiving Generia Rapamycin (dosages include 2,3,6, or 8mg) once per week |
Who may qualify
- Ages
- 40 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who sought rapamycin prescription for longevity support, pain reduction, energy improvement, weight loss, mood improvement, sleep improvement, or oral health improvement were included in the study. To be eligible to receive AgelessRx's standard rapamycin treatment protocol, participants had to be ≥40 years of age, without a history of uncontrolled disease. All patients treated with rapamycin and opted for at least one blood draw test between May 1, 2023, and December 15, 2023, were included in this retrospective study.
Key inclusion criteria (2 listed)
- Receive AgelessRx's standard Rapamycin treatment protocol
- Opted to complete at least 1 blood draw at their local Quest Lab
Key exclusion criteria (3 listed)
- Not approved for current AgelessRx standard Rapamycin treatment
- History of uncontrolled disease
- Unable to complete at least 1 blood draw at their local Quest Lab
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 |
|---|---|---|
| RapamycinAlso: Sirolimus, Rapamune, Rapacan, SiromusRapamycin in 2 different dosage forms (compounded and generic) | Drug | Compounded Rapamycin, Generic Rapamycin |
Primary outcome
define the relative bioavailability ratio between compounded rapamycin and generic rapamycin
Time frame: 8 months
define the relative bioavailability ratio between compounded rapamycin and generic rapamycin, with a specific focus on relative efficacy in increasing rapamycin levels in the blood (blood rapamycin levels).
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 13 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Sajad Zalzala, MD study director
AgelessRx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by AgelessRx 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 2 inclusion and 3 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 13 Aug 2024. 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.
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?
define the relative bioavailability ratio between compounded rapamycin and generic rapamycin (time frame: 8 months). 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 13 Aug 2024.