MTOR Inhibitors in Older Adults

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06727305
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Aging

Eligibility Criteria

Sex
ALL
Age
65 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Sirolimus 0.5 Mg Oral Tablet — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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 — DRUG
    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.

Study Details

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

Key Dates

Start date
Feb 28, 2026
Status verified
Jan 2026
Primary completion
Sep 1, 2027
Completion
Nov 13, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: sirolimus 0.5 mg Arm
    Participant would receive 0.5 mg of sirolimus.
  • Active Comparator: sirolimus 1 mg Arm
    Participant would receive 1 mg of sirolimus.
  • Active Comparator: sirolimus 2 mg Arm
    Participant would receive 2 mg of sirolimus.
  • Active Comparator: everolimus 0.5 mg Arm
    Participant would receive 0.5 mg of Everolimus.
  • Active Comparator: everolimus 1 mg Arm
    Participant would receive 1 mg of Everolimus.
  • Active Comparator: everolimus 2 mg Arm
    Participant would receive 2 mg of Everolimus.

Primary Outcome Measure

Cmax for Sirolimus [ Time Frame: Predose (0 hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24-hour post dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390
Rhoda Annoh Gordon, PharmD, MPH
[email protected]
2146457108

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By research site
UT Southwestern Medical Center· Dallas, TX

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