A study in healthy subjects to see the effects of the test medicine on the body when given in fed or fasted state as a multiple dose

Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: Cohort 1: Participants will receive 1100 mg acoramidis modified release (MR) tablet (2 × 550 mg tablets) once daily orally on Days 1 to 7 in the fasted state. Cohort 2 (optional) Participants will receive either receive 1100 mg acoramidis MR tablet (2 × 550 mg tablets) once daily orally on Days 1 to 7 in the fed state or an alternative dose of acoramidis MR tablet(s) once daily on Days 1 to 7 in the fed or fasted state. For both cohorts, participants will return on Days 11, 12 and 14 for return visits and a follow‐up phone call will take place between 30 and 34 days post‐final dose to ensure the ongoing wellbeing of the subjects. CONDITION: Transthyretin (TTR) Amyloidosis (ATTR) ; Digestive System PRIMARY OUTCOME: ; 1. Measurement of the PK parameters of acoramidis (AG10) and acoramidis‐AG including but not limited to: Tmax, Cmax, Cmin (Day 7), Ctrough (Day 7), C24, AUC(0‐tau), AUC(0‐last) (Day 7), AUC(0‐inf) (Day 7) and T1/2 (Day 7); 2. Assessment of dose accumulation of AG10 and acoramidis‐AG for Cmax and AUC(0‐tau) (Day 7 vs Day 1); SECONDARY OUTCOME: ; 1. Measurement of the PK parameters of acoramidis (AG10) and acoramidis‐AG including but not limited to: Tmax, Cmax, Cmin (Day 7), C24, AUC(0‐tau), AUC(0‐last) (Day 7), AUC(0‐inf) (Day 7) and T1/2 (Day 7); Assessment of dose accumulation of AG10 and acoramidis‐AG for Cma Xand AUC(0‐tau) (Day 7 vs Day 1); 2. Assessment of the relative bioavailability for Cmax, AUC(0‐tau), AUC(0‐last) and AUC(0‐inf), as appropriate in the fed vs fasted state; 3. Measurement of the PK parameters of AG10 and acoramidis‐AG including but not limited to: Tmax, Cmax, Cmin (Day 7), C24, AUC(0‐tau), AUC(0‐last), AUC(0‐inf) (Day 7) and T1/2; 4. Assessment of dose accumulation of AG10 and acoramidis‐AG for Cma Xand AUC (0‐tau) (Day 7 vs Day 1); 5. Assessment of dose corrected PK parameters Cmax, AUC(0‐tau), AUC(0‐last) and AUC(0‐inf), as appropriate at XXmg in the fasted state vs; 1100 mg in the fasted state; 6. Assessment of incidence of adverse events (AEs), physical examinations, vital signs, electrocardiograms (ECGs), and laboratory safety tests; INCLUSION CRITERIA: 1. Must provide written informed consent 2. Must be willing and able to communicate and participate in one cohort 3. Aged 18 to 65 years inclusive at the time of signing informed consent 4. Must agree to adhere to the contraception requirements 5. Healthy males or non‐pregnant, non‐lactating healthy females 6. Body mass inde X(BMI) of 18.0 to 32.0 kg/m² as measured at screening 7. Body weight >50 kg at screening
Epistemonikos ID: 5ce17bb9c70eb2b5cd6451d97506f20d13e813f4
First added on: Aug 26, 2022