None listed
Conditions
Brief summary
This study will compare the bioavailability and biological effects of generic oral rapamycin with a sublingual (under-the-tongue) rapamycin formulation in healthy adults aged 30–60 years. Participants will be randomised to receive a single 6 mg dose of either oral or sublingual rapamycin. Blood samples will be collected at multiple time points over 72 hours to assess the bioavailability of rapamycin. Sirolimus blood concentrations and changes in immune-related gene expression, including pathways related to mTOR signalling, will be measured. The findings will determine whether sublingual administration improves rapamycin bioavailability and molecular response compared with standard oral dosing, informing future clinical research on rapamycin use for healthspan and longevity.
Interventions
Group 1 - a single 6mg dose of a generic rapamycin liquid (1mg/ml) orally. Research staff will ensure all of the medication has been taken as intended by conducting visual mouth checks.
Sponsors
Australian Longevity Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
- Be aged 30-60 years; - A body mass index between 18-28 kg/m2
Exclusion criteria
- Report antibiotic, probiotic or symbiotic use in the previous 14 days; - Report gastrointestinal or respiratory disease, autoimmune disease or other diseases, in particular Crohn’s Disease or Ulcerative Colitis; - Report a medication allergy to Rapamycin - Report use of any medications that are contraindicated with Rapamycin - Pregnant women will be excluded. - Individuals who are immunosuprressed taking immunosuppressive medications or a cancer diagnosis will be excluded
Outcome results
None listed