RecruitingPhase 1Phase 2NCT06727305

MTOR Inhibitors in Older Adults

Characterization of mTOR Inhibitor Pharmacokinetics and Pharmacodynamics in Older Adults .

Sponsor

University of Texas Southwestern Medical Center

Enrollment

60 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Aging

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

Eligibility

Min Age: 65 YearsMax Age: 80 Years

Inclusion Criteria3

Community-dwelling adults
Patients should be 65 Years and older
Patients is able to understand and follow trial procedures

Exclusion Criteria10

Creatinine clearance <30 mL/min;
History of chronic liver disease;
Uncontrolled Hypertension (i.e., systolic blood pressure >160 mm Hg);
Hemorrhagic central nervous system (CNS) event within 1 year from screening visit;
Thrombotic event (DVT,PE) within 1 year from screening visit if not on anticoagulation;
Planned major surgical procedures;
Cardiovascular diseases ( i.e., admission for heart failure or myocardial infarction within 12 months);
Taking medication that increase or decrease sirolimus blood concentrations;
Other investigational therapy received within 1 month prior to screening visit;
History of dementia; 11 Dependence in any Katz Basic Activities of Daily Living.

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Interventions

DRUGSirolimus 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.

DRUGSirolimus 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.

DRUGSirolimus 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.

DRUGEverolimus 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.

DRUGEverolimus 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.

DRUGEverolimus 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.