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RAP PAC Study for Aging

This study, called RAP PAC, is looking for a safe and effective weekly dose of two medications, sirolimus and everolimus, to understand how they affect the biology of aging. You might be able to join if you are between 55 and 89 years old and generally healthy, without major chronic diseases. Participants will take either sirolimus or everolimus once a week for six weeks. The study aims to find the right dose that works best while minimizing side effects. The study's status is currently unclear, and it plans to enroll 72 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 72 participants to test different doses of sirolimus and everolimus.
What's involved
You would take an oral medication (sirolimus or everolimus) once a week for six weeks. The total time on the study, including initial and follow-up visits, would be up to 17 weeks.
Compensation
Not stated in the trial record.
Follow-up
The study will monitor for Dose Limited Toxicities (DLTs) through study completion, which is an average of 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05949658

Rapalog Pharmacology (RAP PAC) Study

Recruiting
PHASE1Ages 55–89InterventionalBasic science
University of Wisconsin, Madison
~72 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:SirolimusEverolimus

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Limited Toxicities (DLTs)
Measured over Through study completion, an average 3 years

Conditions

Aging

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Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Wisconsin

    Madison, Wisconsinno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Adam Konopka, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Brittany Grasso
[email protected]
608-263-2386
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

Exclusion

Heart disease (history, abnormal ECG)
Cerebrovascular disease (history)
Cancer or less than 5 years in remission (history)
Chronic respiratory disease (history, FEV1/FVC \< 70, FEV1 \< 80% predicted)
Chronic liver disease (history, abnormal blood liver panel, ALT \>104 IU/L, AST \>80 IU/L)
Diabetes (history, HbA1C ≥ 6.5, fasting blood glucose≥126 mg/dl, OGTT ≥ 200 mg/dl at 2 hrs.)
Alzheimer's (history)
Chronic kidney disease (history, abnormal blood kidney panel including serum creatinine\>1.4, eGFR≤60 ml/min/1.73m2)
Problems with bleeding, on medication that prolongs bleeding time (if subject cannot safely stop prior to biopsy)
Taking azathioprine (Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), dexamethasone (Decadron, Dexpak), methotrexate (Rheumatrex, Trexall), prednisolone (Orapred, Pediapred, Prelone), prednisone (Sterapred), sirolimus (Rapamune), and tacrolimus (Prograf) or other medications proposed to lower the immune system
Taking strong or moderate CYP3A4 and/or P-glycoprotein (PgP) inhibitors such as ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole, amprenavir, fosamprenavir, aprepitant, erythromycin, fluconazole, verapamil, diltiazem
Taking strong or moderate CYP3A4 and/or P-glycoprotein (PgP) inhibitors such as ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole, amprenavir, fosamprenavir, aprepitant, erythromycin, fluconazole, verapamil, diltiazem
Taking strong CYP3A4 activators such as phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital
Taking daily NSAIDs such as ibuprofen, naproxen, aspirin and others, with the exception of baby aspirin (81mg)
Subjects who are not willing to restrict the use of grapefruit, grapefruit juice, cannabidiol (CBD) and other foods/substances that are known to inhibit cytochrome P450 and PgP activity and may increase everolimus exposures and should be avoided during treatment
Subjects who are not willing to restrict the use of St. John's Wort (Hypericum perforatum) because it may decrease everolimus exposure unpredictably.
Subjects who are not willing to avoid blood donations 8 weeks prior to the first visit and 8 weeks after the last visit
Low white-blood cell count (\<4,000 cell/µL)
History of stomatitis or ulcers in the mouth
Those on glucose lowering drugs
Participating in intensive exercise training program (high to moderate intensity exercise greater than 150 minutes per week) or planning to start new exercise program during study period
Tobacco or nicotine use
Allergies to lidocaine, sirolimus, or everolimus
Subjects currently enrolled in other clinical trials. Subjects may be eligible after a washout period that will be reviewed on a case-by-case basis.
Individuals with limited English proficiency
Subjects who are planning to have elective surgery 12 weeks prior to or during the intervention

What this trial measures

  • Dose Limited Toxicities (DLTs)Through study completion, an average 3 years

    A recommended phase 2 dose (RP2D) will be determined through evaluating dose limiting toxicities (DLT), which is defined as ≥Grade 2 adverse event following CTCAE v6.0.