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MTOR Inhibitors in Older Adults
Sponsor: University of Texas Southwestern Medical Center
Summary
Over the past decades, healthcare systems face significant challenges to meet the needs of an aging population due to progressive debility, functional decline and chronic diseases development. While there is a growing appreciation of the potential impact of mTOR inhibitors on slowing aging processes, preventing chronic disease and prolonging healthy lifespan, a major challenge in developing clinical trials to establish the clinical efficacy of mTOR inhibitors is the absence of pharmacokinetics (PK) and pharmacodynamics (PD) data in older adults. The proposed study will provide the foundation for future clinical trials assessing the role of mTOR inhibitors on aging related indications
Official title: Characterization of mTOR Inhibitor Pharmacokinetics and Pharmacodynamics in Older Adults .
Key Details
Gender
All
Age Range
65 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-02
Completion Date
2027-11-13
Last Updated
2026-02-02
Healthy Volunteers
Yes
Conditions
Interventions
Sirolimus 0.5 Mg Oral Tablet
Sirolimus 0.5 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Sirolimus 1Mg Oral Tablet
Sirolimus 1 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Sirolimus 2 MG Oral Tablet
Sirolimus 2 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Everolimus 0.5 MG Oral Tablet
Everolimus 0.5 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Everolimus 1 MG Oral Tablet
Everolimus 1 mg oral tablets daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Everolimus 2 MG Oral Tablet
Everolimus 2 mg oral tablets for daily for 2 weeks and complete PK/PD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng/ml.
Locations (1)
UT Southwestern Medical Center
Dallas, Texas, United States