The Bioavailability of Compounded and Generic Rapamycin in Normative Aging Individuals

NCT ID: NCT06550271

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-25

Study Completion Date

2023-12-15

Brief Summary

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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).

Detailed Description

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Conditions

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Aging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Compounded Rapamycin

Participants in this group were receiving Compounded Rapamycin (dosages include 5, 10, or 15mg) once per week

Rapamycin

Intervention Type DRUG

Rapamycin in 2 different dosage forms (compounded and generic)

Generic Rapamycin

Participants in this group were receiving Generia Rapamycin (dosages include 2,3,6, or 8mg) once per week

Rapamycin

Intervention Type DRUG

Rapamycin in 2 different dosage forms (compounded and generic)

Interventions

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Rapamycin

Rapamycin in 2 different dosage forms (compounded and generic)

Intervention Type DRUG

Other Intervention Names

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Sirolimus Rapamune Rapacan Siromus Raparen Rapasim Sirova

Eligibility Criteria

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Inclusion Criteria

* Receive AgelessRx's standard Rapamycin treatment protocol
* Opted to complete at least 1 blood draw at their local Quest Lab

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AgelessRx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sajad Zalzala, MD

Role: STUDY_DIRECTOR

AgelessRx

Locations

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AgelessRx

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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ALRx005

Identifier Type: -

Identifier Source: org_study_id

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