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MTOR Inhibitors for Aging in Older Adults

This study is looking at how two medications, sirolimus and everolimus, work in older adults. These medications are called mTOR inhibitors and are being studied for their potential to slow down aging processes and prevent chronic diseases. Researchers want to understand how these drugs are processed by the body (pharmacokinetics or PK) and what effects they have (pharmacodynamics or PD) in people aged 65 and older. The study will also look at whether these medications can improve certain markers related to aging. This research aims to provide important information for future studies on mTOR inhibitors and aging.

Study design
This interventional study plans to enroll 60 participants. It is not specified if it is randomized or blinded.
What's involved
You would take either sirolimus or everolimus tablets daily for at least 2 weeks. You would also have blood tests at specific times to measure drug levels.
Compensation
Not stated in the trial record.
Follow-up
The study aims to assess biomarkers of aging at 3 months follow-up.

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

NCT06727305

MTOR Inhibitors in Older Adults

Recruiting
PHASE1Ages 65–80InterventionalPrevention
University of Texas Southwestern Medical Center
~60 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Sirolimus 0.5 Mg Oral TabletSirolimus 1Mg Oral TabletSirolimus 2 MG Oral TabletEverolimus 0.5 MG Oral TabletEverolimus 1 MG Oral TabletEverolimus 2 MG Oral Tablet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cmax for Sirolimus
Measured over Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose
+14 more outcomes measured

Conditions

Aging

Explore related trials

AgingDisabilityGeriatric

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Irina Timofte, MD, MS · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Irina Timofte, MD, MS
[email protected]
2163347534
Email the study team

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

What this trial measures

  • Cmax for SirolimusPredose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose

    Maximum Sirolimus Concentration at Steady State (Cmax)

  • Cmax for EverolimusPredose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 12-hour post dose

    Maximum Everolimus Concentration at Steady State (Cmax)

  • Ctrough for SirolimusPredose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose

    Trough Sirolimus Concentration at Steady State (Ctrough)

  • Ctrough for EverolimusPredose (0 hour) on Day 14 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 12-hour post dose

    Trough Everolimus Concentration at Steady State (Ctrough)

  • AUC for SirolimusPredose (0 hour) on Day 14 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose

    Sirolimus Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau) at Steady State

  • AUC for EverolimusPredose (0 hour) on Day 14 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 12-hour post dose

    Everolimus Area Under the Curve from Time Zero to End of Dosing Interval (AUCtau) at Steady State

  • CL/F for SirolimusPredose (0 hour) on Day 14 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose

    Sirolimus Apparent Oral Clearance (CL/F)

  • CL/F for for EverolimusPredose (0 hour) on Day 14 and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 12-hour post dose

    Everolimus Apparent Oral Clearance (CL/F)

  • S6K Activity, in Sirolimus cohortsPredose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose on Day 1 and Day 14

    Pharmacodynamic parameter, S6K Activity, in Sirolimus cohorts

  • S6K Activity, in Everolimus cohortsPredose (0 hour) on Day 14 and 0.5, 1, 1.5, 2.5, 3, 4, 6, and 12-hour post dose on Day 1 and Day 14

    Pharmacodynamic parameter, S6K Activity, in Everolimus cohorts

  • Senescence-associated secretory phenotype (SASP) indexDay 1 Week 1 (Baseline), Week 5, Week 9, Week 13

    Clinical biomarker parameter (SASP) index is a clinical biomarker parameter that measures the level of proteins secreted by senescent cells in the body.

  • Erythrocyte sedimentation rate (ESR)Day 1 Week 1 (Baseline), Week 5, Week 9, Week 13

    Clinical biomarker parameter (ESR) is a blood test that detects and monitors inflammation in the body.

  • C-reactive protein (CRP)Day 1 Week 1 (Baseline), Week 5, Week 9, Week 13

    A measure of Clinical biomarker parameter (CRP), is an inflammatory marker.

  • 6-minute walk test (6MWT)Day 1 Week 1 (Baseline), Week 5, Week 9, Week 13

    The 6MWT is simply a record of the distance (in meters) traveled by a given patient at his or her self-selected walking speed over a period of six minutes.

  • Short physical performance battery (SPPB)Day 1 Week 1 (Baseline), Week 5, Week 9, Week 13

    Clinical biomarker parameter (SPPB) assesses lower extremity function in older adults. The test battery consists of three physical tasks (walking, sit-to-stand and balance) to assess functional mobility. The test will be performed according to standardized procedure. The maximal total score is 12 and higher total scores indicate a better lower extremity functioning.