Bioavailability and Food Effect of the Original Gelatin Formulation and Two New Formulations of Afuresertib in Normal Healthy Volunteers
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, open-label, sequential, single dose, 4-period crossover study.
      This study is being conducted to measure the relative bioavailability of the original gelatin
      capsule (GC) formulation and two new formulations (hydroxypropyl-methylcellulose [HPMC]
      capsule and enteric coated tablet [ECT]) of afuresertib (AFU), in the fed and fasted state.
      The study will be composed of Screening, Treatment, and Follow-up Periods. Screening
      assessments to determine subject eligibility will be performed within 3 weeks prior to the
      first dose of study drug in the Treatment Period. Eligible subjects will be randomized to
      receive 4 of the 6 possible study treatments (A: AFU GC administered in a fasted state, B:
      AFU GC administered in a fed state, C: AFU HPMC capsule administered in a fasted state, D:
      AFU HPMC capsule administered in a fed state, E: AFU ECT administered in a fasted state, F:
      AFU ECT administered in a fed state) in 4 treatment periods (one per treatment period).
      Subjects will receive a single dose of one of the six study treatments (A, B, C, D, E, F) on
      Day 1 of each Dosing Period, according to one of the 6 treatment sequences (CEDA, EFAB, ABFC,
      BDCE, FCBD, DAEF). There will be a minimum of 10 Day washout period between the doses
      administered in each Treatment Period. A Follow-up visit will be conducted within 10-14 days
      after the last dose. A subject's total time involved in the study will be approximately 9
      weeks. At least 36 subjects will be enrolled in the study, to ensure that at least 6 subjects
      will be randomized to receive each treatment sequence.
    


Intervention name(s): Afuresertib GC - Fasted State; Afuresertib HPMC capsule - Fasted State; Afuresertib ECT - Fasted State; Afuresertib GC - Fed State; Afuresertib HPMC capsule - Fed State; Afuresertib ECT - Fed State
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): White opaque hard gelatin capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib GC administered in fasted state; White opaque HPMC capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib HPMC capsule administered in fasted state; White to off white, round, biconvex coated tablet containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib ECT administered in fasted state; White opaque hard gelatin capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib GC administered in fed state; White opaque HPMC capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib HPMC capsule administered in fed state; White to off white, round, biconvex coated tablet containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib ECT administered in fed state
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AKT inhibitor; formulation; food effect; bioavailability; GSK2110183