A Study to Compare Bioavailability of AZD5055 Film-coated Tablet With AZD5055 Oral Suspension and to Assess the Effect of Food and an Acid Reducing Agent on Pharmacokinetics (PK) of AZD5055 in Healthy Subjects.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): AZD5055 solution for infusion; AZD5055 oral suspension; AZD5055 film-coated tablet; AZD5055 film-coated tablet; Rabeprazole, Delayed-release tablet; Rabeprazole, Delayed-release tablet
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acid Reducing Agent; Bioavailability; Healthy subjects; pH-dependent solubility; Food Effect