A Crossover Study to Evaluate the Bioavailability of Ibrutinib Suspension and Sprinkle Formulations Compared to Capsules in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the relative bioavailability (the extent to which a
      drug or other substance becomes available to the body) of ibrutinib in healthy adults
      following single oral dose administration of suspension and sprinkle formulations under fed
      and fasted conditions compared with capsules under fasted conditions.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), randomized (study
      medication assigned to participants by chance), 3- or 4-way crossover (participants may
      receive different interventions sequentially during the trial), and single-center study of
      ibrutinib. The duration of study will be approximately 67 to 83 days per participant. The
      study consists of 3 parts: Screening (28 days before study commences on Day 1); Open-label
      Treatment (consists of 6 treatments, either Ibrutinib capsule or suspension or sprinkle
      capsule granules under fed or fasted condition), in subsequent 3 periods for Group 1 and 4
      periods for Group 2, each separated with washout period of 7 (plus [+] / minus [-] 2) days;
      and follow up Phase (up to 10 + / - 2 days after last study drug administration). All the
      eligible participants will be randomly assigned to 1 of the 6 (Group 1) or 4 (Group 2)
      treatment sequences. In fasted conditions, study drug will be administered following a
      10-hour overnight fast. In fed conditions, participants will also fast from food for 10
      hours, but will consume a high fat breakfast within a 30-minute period. Study drug will be
      administered 2 hours after the breakfast. Participants will not be allowed to have food until
      4 hours of drug administration. Blood samples will be collected for evaluation of
      pharmacokinetics at pre-dose and post-dose of study treatment. Relative bioavailability of
      Ibrutinib will be evaluated primarily. Participants' safety will be monitored throughout the
      study.
    

Intervention name(s): Ibrutinib (Treatment A) [Reference]; Ibrutinib (Treatment B); Ibrutinib (Treatment C); Ibrutinib (Treatment D); Ibrutinib (Treatment E); Ibrutinib (Treatment F)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive Ibrutinib 560 milligram (mg) (4*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods.; Participants will receive Ibrutinib 560 mg suspension as Treatment B under fasted conditions in one of the treatment periods.; Participants will receive Ibrutinib 560 mg suspension as Treatment C under fed (high-fat) conditions in one of the treatment periods.; Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment D under fasted conditions in one of the treatment periods.; Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment E under fed (high-fat) conditions in one of the treatment periods.; Participants will receive Ibrutinib 560 mg sprinkle capsule granules suspended in water as Treatment F under fasted conditions in one of the treatment periods.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Ibrutinib; Bioavailability