This study will estimate the relative bioavailability of AZD5055 film-coated tablet as compared to AZD5055 oral suspension. The study will also assess the absolute bioavailabilty of AZD5055 and the effect of food and an acid reducing agent, rabeprazole, on the PK of AZD5055 film-coated tablets when given with food (fed state) or without food (fasted state).
This will be an Open-Label, Five-Period Study in healthy subjects. The study will comprise of a Screening Period of maximum 28 days. The treatment groups are as follows: * Treatment A: AZD5055 solution for infusion as 20-minute infusion and an overnight fasted state after the 20-minute infusion. * Treatment B: AZD5055 oral suspension and an overnight fasted state after the oral suspension. * Treatment C: AZD5055 film-coated tablet and an overnight fasted state after the film-coated tablet.. * Treatment D: AZD5055 film-coated tablet, fed state (after a high-fat, high-calorie standard breakfast). * Treatment E: Twice daily oral doses of 20 mg rabeprazole for 3 days prior a single dose of AZD5055 film-coated tablet under fasted conditions, and then rabeprazole will be continued for 2 days. * Treatment F: Twice daily oral doses of 20 mg rabeprazole continuing from Treatment E prior to a single dose of AZD5055 film-coated tablet under fed conditions (low-fat standard breakfast) and then rabeprazole will be continued for 2 days. Five (5) periods during which subjects will participate from Day -1 of Period 1 to 72 hours after the AZD5055 dose in Period 5. * Period 1: On Day 1, the subjects will receive either Treatment A or Treatment B. * Period 2: On Day 4, the subjects will receive Treatment C. * Period 3: On Day 8, the subjects will receiveTreatment D. * Period 4: On Day 10, three days prior to Day 1, rabeprazole will be administered twice daily. On Day 13, subject will receive Treatment E. * Period 5: On Day 17, the subjects will receive Treatment F. Rabeprazole will continue twice daily, the last dose is on the evening of Study Day 18. A Follow-up Visit, or telephone call, approximately 6 days after the last AZD5055 dose in Period 5. There will be a minimum washout of 3 days between the AZD5055 dose administration in Period 1 and Period 2 and a minimum washout of 4 days between AZD5055 doses administrations for subsequent study periods. Each subject will participate in the study for approximately 8 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Subjects will receive a single dose intravenous infusion of AZD5055 as 20-minute infusion on Day 1 of the respective period in overnight fasted state.
Subjects will receive single dose of AZD5055 oral suspension on Day 1 of the respective period in overnight fasted state.
Subjects will receive single oral dose of AZD5055 film-coated tablets on Day 1 of the respective period in overnight fasted state.
Research Site
Brooklyn, Maryland, United States
Area under concentration time curve from time 0 to infinity (AUCinf)
* To estimate the relative bioavailability of AZD5055 film-coated tablet formulation versus AZD5055 oral suspension formulation. * To estimate the absolute bioavailability of AZD5055 oral suspension and AZD5055 film-coated tablet formulation. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055 alone and in combination with acid reducing agent. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055, when AZD5055 is administered.
Time frame: Day 1-6, 8-10, 13-15, 17-19
Area under the concentration time curve from time 0 to the last quantifiable concentration (AUClast)
* To estimate the relative bioavailability of AZD5055 film-coated tablet formulation versus AZD5055 oral suspension formulation. * To estimate the absolute bioavailability of AZD5055 oral suspension and AZD5055 film-coated tablet formulation. * To assess the effect of food on the pharmacokinetic (PK) parameters of AZD5055 in the fed and fasted state. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055 alone and in combination with acid reducing agent. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055, when AZD5055 is administered in fasted and fed state.
Time frame: Day 1-6, 8-10, 13-15, 17-19
Maximum observed concentration (Cmax)
* To estimate the relative bioavailability of AZD5055 film-coated tablet formulation versus AZD5055 oral suspension formulation. * To estimate the absolute bioavailability of AZD5055 oral suspension and AZD5055 film-coated tablet formulation. * To assess the effect of food on the pharmacokinetic (PK) parameters of AZD5055 in the fed and fasted state. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055 alone and in combination with acid reducing agent. * To assess the effect of the acid reducing agent, rabeprazole, on the PK of AZD5055, when AZD5055 is administered in fasted and fed state.
Time frame: Day 1-6, 8-10, 13-15, 17-19
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Subjects will receive single oral dose of AZD5055 film-coated tablets on Day 1 of the respective period in fed state (either a high fat meal or low-fat meal calorie standard breakfast)
Subjects will receive oral doses of rabeprazole twice daily 3 days prior to AZD5055 single dose and 4 days after the AZD5055 single dose including the day that AZD5055 is dosed under fasted conditions \[Study Day 10 to 18\].
Subjects will receive oral doses of rabeprazole twice daily prior to AZD5055 single dose under fed conditions (low-fat standard breakfast) and then continued for 2 days.