Rapalog Pharmacology (RAP PAC) Study

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT05949658
Phase
PHASE1
Status
Recruiting

Conditions

  • Aging

Eligibility Criteria

Sex
ALL
Age
55 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • Sirolimus — DRUG
    5mg, 10mg, or 15mg once weekly sirolimus
  • Everolimus — DRUG
    5mg, 10mg, or 15mg once weekly everolimus

Study Details

The objective of RAP PAC is to identify safe and effective weekly dose(s) for the mTOR inhibitors sirolimus and everolimus that intervene on the underlying fundamental biology of aging. Participants who are 55-89 years old that are free of overt chronic diseases will be assigned to either 6 weeks of sirolimus or everolimus (5 mg, 10 mg, or 15 mg once per week). The investigators will complete the everolimus arm first and then subsequently complete the sirolimus arm of the study. Total time on study would be up to 17 weeks to complete baseline and follow up visits.

Key Dates

Start date
May 15, 2024
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Sirolimus
    1mg tablets of sirolimus that total the assigned dose
  • Experimental: Everolimus
    1mg tablets of everolimus that total the assigned dose

Primary Outcome Measure

Dose Limited Toxicities (DLTs) [ Time Frame: Through study completion, an average 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WisconsinMadisonWisconsin53705
Adam Konopka, PhD (PRINCIPAL_INVESTIGATOR)

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