A Clinical Study Comparing eRapa and Rapamune in Healthy Adult Volunteers.

INTERVENTION: Single oral dose of 0.5 mg eRapa capsules given under fasted conditions. Intervention period: includes randomisation, pre‐treatment procedures, administration of a single dose of eRapa and Rapamune, and various assessments according to the Schedule of Activities as per the protocol. Each participant will complete two treatment periods, one for each trial drug, separated by a washout interval. After the washout, pre‐treatment procedures will be repeated starting from Day ‐1 in preparation for the second treatment period. • 7 days: Period 1 Study Intervention • 14‐20 days: Washout interval between each intervention as required. Patients will be required to fast for atleast 8 hours prior to each intertention and with no food consumed at least 2 hours post dose. Total duration of intervention = approximately 82 days PK blood samples will be collected pre dose and post dose to assess study concentrations in the blood. CONDITION: Cancer ‐ Other cancer types familial adenomatous polyposis ; ; familial adenomatous polyposis Human Genetics and Inherited Disorders ‐ Other human genetics and inherited disorders Oral and Gastrointestinal ‐ Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon PRIMARY OUTCOME: To assess the PK of a single dose of eRapa versus Rapamune administered under fasted conditions in healthy adult participants[PK parameters for both eRapa and Rapamune include:; 1. maximum observed concentration Cmax),,; 2. time to maximum observed concentration (Tmax),; 3. area under the truncated concentration‐time curve from dosing to 72 hours (AUC072h),; 4. AUC from the time of dosing extrapolated to time infinity (AUC08),; 5. AUC from the time of dosing to the last measured concentration (AUC0‐tlast),; 6. 24‐hour AUC (AUC24),; 7. half‐life (t1/2),; 8. mean residence time (MRT),; 9. apparent volume of distribution/bioavailability (Vz/F),; 10. and apparent clearance (CL/F) (if data permit). Time windows for PK blood sample collection are: ; 1. pre‐dose (up to 45 minutes before dosing); ; 2. 0.5h, 1h, 2h, 3h, 4h post dose ±5 minutes window; ; 3. 6h, 8h, 12h, 24h, 48h, 72h, 96h post dose, ±15 minutes; ; 4. 144 hours post‐dose, ± 4 hours.] SECONDARY OUTCOME: The safety and tolerability of single doses of eRapa will be evaluated as a composite secondary endpoint in healthy adult participants.[• Vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate and oral temperature) recorded after the participant has been supine for at least 5 minutes. . Blood pressure to be measured with a sphygmomanometer as per institution's standard of care calibrated equipment. ; • Physical examinations findings. To be evaluated by the investigator. ; • 12‐lead digital electrocardiogram (ECG) parameters. Triplicate 12‐lead ECGs will be obtained in supine position after the participant has been supine for at least 5 minutes prior to any scheduled blood collection for laboratory tests using the institution's standard of care calibrated ECG machine capable of ; automatically calculating heart rate and measuring PR, QRS, QT, and QTc intervals. ; • Incidence and severity of treatment‐emergent adverse events (TEAEs) graded using the Common Terminology Criteria for Adverse Events (CTCAE v 5.0) ; • Incidence and severity of TEAS leading to withdrawal ; • Incidence and magnitude of treatment‐emergent clinical laboratory abnormalities including haematology (with differentials), chemistry, glucose, lipids, urinalysis and pregnancy test. • Vital signs (screening, Day1, Pre‐dose, Day1‐2h, Day1‐4h, Day1‐12h, Day2, Day3, Day4, Day5, Day7, 30days post dose) ; • Physical examinations (screening, Day1, 30days post dose) ; • ECG (screening, Day1, Pre‐dose, Day1‐2h, Day1‐3h, Day1‐4h, Day1‐12h, Day2, Day5, Day7, 30days post dose). ; • adverse events (TEAEs) and withdrawals due to TEAEs to be assessed from screening to 30days post dose ; • Safety Laboratory bloods to be collected screening, Day1, Day3 and 30days post dose ; • Safety urinalysis to be collected screening, Day1, Day3 and 30days post dose] INCLUSION CRITERIA: 1. Male or female participants who are overtly healthy as determined by screening study assessments. 2. Participants must be between 18 and 65 years of age inclusive, at the time of signing the consent form. 3. A body mass inde X(BMI) within the range 18 and 32 kg/m2 inclusive. 4. Male and/or female assigned at birth, inclusive of all gender identities. Male participants are eligible to participate if they agree to the following prior to the first dose of study intervention, during the study, and for 90 days plus 5 half‐lives of eRapa after the last dose of study intervention: • Refrain from donating sperm • Be abstinent from intercourse where pregnancy can occur (abstinent on a long term and persistent basis) and agree to remain abstinent, OR Must agree to use contraception/barrier as detailed below: •. Agree to use an external condom with a partner of childbearing potential, agree to use of an additional highly effective contr