Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05949658
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2023-06-26
Brief Title:
Rapalog Pharmacology RAP PAC Study
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Safer mTOR Inhibition for Human Geroprotection
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of RAP PAC is to identify safe and effective weekly doses for the mTOR inhibitors sirolimus and everolimus that intervene on the underlying fundamental biology of aging Participants who are 55-89 years old that are free of overt chronic diseases will be assigned to either 6 weeks of sirolimus or everolimus 5 mg 10 mg or 15 mg once per week The investigators will complete the everolimus arm first and then subsequently complete the sirolimus arm of the study Total time on study would be up to 17 weeks to complete baseline and follow up visits
Detailed Description:
The mTOR inhibitor rapamycin and rapamycin analogs rapalogs extend healthspan andor lifespan in multiple model systems However the risk of adverse events and dose limiting toxicities in humans have thus far precluded the long-term prophylactic use of mTOR inhibitors as a therapy for aging and age-related diseases The pharmacokinetics and pharmacodynamics PKPD data for mTOR inhibitors in older adults is currently unknown and has prevented the identification of a safe dosage that could maximize health-span extension and minimize adverse effects
RAP PAC will identify a recommended phase 2 trial dose for sirolimus and everolimus in older men and women by performing a phase 1 dose finding study that evaluates PKPD safety and tolerability and mTOR signaling using conventional as well as novel approaches Overall the investigators will pair comprehensive molecular and pharmacologic approaches to evaluate PKPD in humans and identify dosing regimens that safely inhibit mTOR complex 1 mTORC1 to intervene in the biology of aging
RAP PAC will identify a recommended phase 2 trial dose for sirolimus and everolimus in older men and women by performing a phase 1 dose finding study that evaluates PKPD safety and tolerability and mTOR signaling using conventional as well as novel approaches Overall the investigators will pair comprehensive molecular and pharmacologic approaches to evaluate PKPD in humans and identify dosing regimens that safely inhibit mTOR complex 1 mTORC1 to intervene in the biology of aging
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U01AG081482-01 | NIH | None | None |
| SMPHMEDICINEGER-AD DEV | OTHER | None | None |
| Protocol Version 362023 | OTHER | UW Madison | httpsreporternihgovquickSearch1U01AG081482-01 |