Rapalog Pharmacology (RAP PAC) Study
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 everol
| Condition(s) | Aging |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * 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 Criteria: * Heart disease (history, abnormal ECG) * Cerebrovascular disease (history) * Cancer or less than 5 years in remission (history) * Chronic respiratory diseas |
| Ages | 55 Years to 89 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of Wisconsin, Madison |
| Locations | Madison, Wisconsin, United States |
| Start date | 2024-05-15 |
| NCT ID | NCT05949658 |
| Official listing | https://clinicaltrials.gov/study/NCT05949658 |