The Bioavailability of Compounded and Generic Rapamycin in Normative Aging Individuals

NCT06550271 | Completed FDA Drug

• 1 other identifier: ALRx005
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Aging

Keywords

Bioavailability; Rapamycin; Aging; Longevity; Sirolimus; Healthy aging; age-related conditions; energy improvement

Outcome Measures

Primary Outcomes (1)

• 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).

  8 months

Study Arms (2)

Compounded Rapamycin

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

Drug: Rapamycin

Generic Rapamycin

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

Drug: Rapamycin

Interventions

Rapamycin DRUG

Rapamycin in 2 different dosage forms (compounded and generic)

Also known as: Sirolimus, Rapamune, Rapacan, Siromus, Raparen, Rapasim, Sirova

Compounded Rapamycin; Generic Rapamycin

Eligibility Criteria

• Age: 40 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• AgelessRx: lead

Study Sites (1)

AgelessRx

Ann Arbor, Michigan, 48104, United States

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Sajad Zalzala, MD

  AgelessRx

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: April 25, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

US (1)