Actively Recruiting
Rapalog Pharmacology (RAP PAC) Study
Led by University of Wisconsin, Madison · Updated on 2026-02-10
72
Participants Needed
1
Research Sites
237 weeks
Total Duration
On this page
Sponsors
U
University of Wisconsin, Madison
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rapalog Pharmacology (RAP PAC) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Middle-age adults free of overt chronic disease
- Willing to provide informed consent
- Willing to comply with all study procedures and be available for the duration of the study
- Able to use and be contacted by telephone
- Ability to take oral medication
- Not planning to change diet or physical activity status
- Adequate organ function as indicated by standard laboratory tests: hematology (complete blood count), and clinical chemistry
- Males must agree to avoid impregnation of women during and for four weeks after completing study visits through use of an acceptable method of contraception
You will not qualify if you...
- History of heart disease or abnormal ECG
- History of cerebrovascular disease
- History of cancer or less than 5 years in remission
- History of chronic respiratory disease or abnormal lung function tests
- History of chronic liver disease or abnormal liver blood tests (ALT >104 IU/L, AST >80 IU/L)
- History of diabetes or abnormal blood sugar tests
- History of Alzheimer's disease
- History of chronic kidney disease or abnormal kidney blood tests
- Problems with bleeding or on medications that prolong bleeding time if they cannot safely stop prior to biopsy
- Taking immune-suppressing medications such as azathioprine, cyclosporine, dexamethasone, methotrexate, prednisolone, prednisone, sirolimus, or tacrolimus
- Taking strong or moderate CYP3A4 and/or P-glycoprotein inhibitors or activators
- Unwilling to avoid grapefruit, cannabidiol, St. John's Wort, or other substances affecting drug metabolism during treatment
- Unwilling to avoid blood donations 8 weeks before and after study visits
- Low white blood cell count (<4,000 cells/µL)
- History of stomatitis or mouth ulcers
- Currently on glucose-lowering drugs
- Participating in or planning to start high to moderate intensity exercise (>150 minutes per week)
- Tobacco use
- Allergies to lidocaine, sirolimus, or everolimus
- Currently enrolled in other clinical trials without an approved washout period
- Limited English proficiency
- Planning elective surgery 12 weeks before or during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
B
Brittany Grasso
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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