AZD4635 Relative Bioavailability Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetics and relative bioavailability of AZD4635 solid oral
      formulation and compare with the nano-suspension reference formulation with the option to
      assess food effect, pH effect and absolute bioavailability
    

Detailed description: 
      This is a single centre, phase 1, open-label randomised, 2-part study to assess the
      pharmacokinetics and relative bioavailability of AZD4635 in non-smoking healthy male
      subjects, with the option to assess food effect, pH effect and absolute bioavailability. It
      is planned to enrol 20 subjects who will participate in both parts of the study. Subjects
      will receive a single-dose of AZD4635 in 6 dosing periods with a minimum washout of 9 days
      between doses.

      Part A is a 2-period randomised crossover study of single doses of AZD4635. Subjects will be
      randomised to receive 50mg AZD4635 nano-suspension (reference) or 50mg AZD4635 solid oral
      formulation, in the fasted state.

      Part B is a 4-period, open-label, randomised, crossover study of single doses of AZD4635 in
      the same subjects from Part A. The treatments selected for Part B will depend on the outcome
      of interim analyses of AZD4635 exposure. Subjects will receive 2 of the following 4
      treatments in dosing periods 3 and 4:

        -  A single dose of AZD4635 solid oral formulation dose after a high fat meal

        -  A single dose of AZD4635 solid oral formulation co-administered with a proton pump
           inhibitor (PPI), lansoprazole (fasted state)

        -  A different single dose (XX mg) of AZD4635 solid oral formulation (fasted state)

        -  Another different single dose (YY mg) of AZD4635 solid oral formulation (fasted state)

      Periods 5 and 6 is a 2-period randomised crossover of two variants of AZD4635 solid oral
      formulation. Subjects will be randomised to receive AZD4635 solid oral formulation variant 1
      in the fasted state or AZD4635 solid oral formulation variant 2 in the fasted state. In
      Periods 5 and 6, Part B an IV microtracer dose of [14C] AZD4635 with solid oral formulation,
      variant 1 will be administered.
    

Intervention name(s): AZD4635 50 mg nano-suspension (reference); AZD4635 solid oral formulation - fasted; AZD4635 solid oral formulation - fed; Lansoprazole and AZD4635 50 mg solid oral formulation; AZD4635 solid oral formulation variant 1 - fasted; AZD4635 solid oral formulation variant 2 - fasted; [14C] AZD4635 IV microtracer - fasted
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive a single dose of AZD4635 50 mg nano-suspension (reference) in the fasted state.; Subjects will receive a single dose of AZD4635 solid oral formulation, in the fasted state.; Subjects will receive a single dose of AZD4635 solid oral formulation, in the fed state.; Subjects will receive lansoprazole 30 mg BID for 5 days followed by a single dose of AZD4635 50 mg solid oral formulation in the fasted state.; Subjects will receive a single dose of AZD4635 solid oral formulation, variant 1 in the fasted state.; Subjects will receive a single dose of AZD4635 solid oral formulation, variant 2 in the fasted state.; Subjects will receive a single dose of [14C] AZD4635 IV microtracer. This intervention will be co-administered with AZD4635 solid oral formulation variant 1.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1, healthy, bioavailability, pharmacokinetics