Phase 1/2Recruiting
MTOR Inhibitors in Older Adults
Characterization of mTOR Inhibitor Pharmacokinetics and Pharmacodynamics in Older Adults .
- Sponsor
- University of Texas Southwestern Medical Center (Academic or other)
- Enrolment
- 60 planned
- Conditions
- Aging
- Interventions
- Sirolimus 0.5 Mg Oral Tablet; Sirolimus 1Mg Oral Tablet; Sirolimus 2 MG Oral Tablet; Everolimus 0.5 MG Oral Tablet; Everolimus 1 MG Oral Tablet; Everolimus 2 MG Oral Tablet
- Ages
- older adults
- Registry
- NCT06727305
From the registry
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
Primary outcomes
- Cmax for Sirolimus
- Cmax for Everolimus
- Ctrough for Sirolimus
- Ctrough for Everolimus