Study to Determine the Single and Repeat Dose Pharmacokinetics, Food Effect, Proton Pump Inhibitor (PPI) Drug Interaction, Safety and Tolerability of Oral Prototype Formulations of BOS172767 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Part 1 of the study will be conducted to provide additional information on the safety and
      tolerability of single doses of BOS172767 in healthy participants, to evaluate the
      pharmacokinetic (PK) profiles (including relative bioavailability) of BOS172767 following
      oral administration of 3 prototype formulations in healthy participants compared to an
      immediate release capsule formulation (reference), and also to determine the relative
      bioavailability of a selected BOS172767 prototype formulation in the fed and fasted states.

      Part 2 of the study will be conducted to provide additional information on the safety and
      tolerability of escalating single doses of the selected formulation of BOS172767 in healthy
      participants, to evaluate the PK profile following increased single doses of the selected
      formulation of BOS172767 following administration in healthy participants, and also to
      evaluate the dose linearity of the selected prototype.

      Part 3 of the study will be conducted to provide additional information on the safety,
      tolerability, and PK of the selected formulation of BOS172767 following multiple ascending
      doses (MADs) over 14 days of dosing in healthy participants.
    

Detailed description: 
      Part 1 is comprised of a single-dose, part-randomized, open-label, 6-way crossover in 12
      healthy participants. Participants will be dosed on 6 separate occasions (in 6 treatment
      periods), and will receive a single prototype of BOS172767 in each treatment period.

      Part 2 is comprised of a single ascending dose, fixed-sequence, open-label, 3-way crossover
      with an optional fourth dosing period in 10 healthy participants. Participants will be dosed
      on 4 separate occasions (in 4 treatment periods), and will receive a single prototype of
      BOS172767 in each treatment period.

      Part 3 is a double-blind (sponsor-open), placebo-controlled, randomized MAD part in 36
      healthy participants (12 per study cohort). Participants will be dosed on 3 separate
      occasions (in 3 treatment periods), and will receive a single prototype of BOS172767 in each
      treatment period.

      Parts 2 and 3 are contingent upon successful completion of Part 1.
    

Intervention name(s): BOS172767 tablets; BOS172767 liquid capsules; BOS172767 micronized capsules; BOS172767 immediate release capsules; BOS172767 matching placebo capsules; BOS172767 matching placebo tablets; Rabeprazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral tablets; Oral capsules; Oral capsules; Oral capsules; Oral capsules; Oral tablets; Oral tablets
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Food Effect; Proton Pump Inhibitors; Drug Interaction; Oral Prototype Formulations