Study of BIIB091 Formulations in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are: to evaluate the pharmacokinetic (PK) profiles of
      BIIB091 modified release (MR) formulations in healthy participants after single dose
      administration in the fasted state (Part 1); to evaluate the PK profile of the BIIB091
      immediate release (IR) tablet formulation in healthy participants after single dose
      administration (Part 1B); to determine the relative bioavailability of single doses of the
      selected BIIB091 regimen in healthy participants taking a proton pump inhibitor (PPI)
      compared to healthy participants not taking a PPI, to determine the relative bioavailability
      of single doses of the selected BIIB091 regimen in healthy participants taking a cytochrome
      P450 (CYP)3A4 inhibitor compared to healthy participants not taking a CYP3A4 inhibitor (Part
      2); to evaluate the PK of the selected BIIB091 regimen in healthy participants after multiple
      dose administration (Part 3).

      The secondary objectives of this study are: to determine the relative bioavailability of a
      single dose of the BIIB091 MR formulations compared to that of the IR drug in capsule (DiC)
      reference formulation in healthy participants in the fasted state, to assess the safety and
      tolerability of single doses of BIIB091 when administered as MR formulations in healthy
      participants in the fasted state (Part 1); to determine the PK of a single dose of the
      BIIB091 IR tablet formulation in the fed and fasted state in healthy participants, to
      evaluate the PK profiles of the BIIB091 IR tablet formulation in healthy participants after
      administration of divided total daily doses over a 24 hour period in the fasted or fed state,
      to determine the relative bioavailability of a single dose or divided dose of the BIIB091 IR
      tablet formulation compared to that of the IR DiC reference formulation in healthy
      participants in the fasted state, to determine the PK of a single or divided dose of the
      BIIB091 IR tablet formulation administered with an alternative meal composition in healthy
      participants, to assess the safety and tolerability of a single or divided dose of BIIB091
      when administered as the IR tablet formulation and IR DiC reference formulation in healthy
      participants in fed or fasted state (Part 1B); to confirm the PK profiles of the selected
      BIIB091 regimen in healthy participants after single dose administration, and to establish a
      reference exposure for the assessment of drug interaction, to assess the safety and
      tolerability of single doses of BIIB091 when administered as the selected BIIB091 regimen in
      healthy participants taking a PPI, to assess the safety and tolerability of single doses of
      BIIB091 when administered as the selected BIIB091 regimen in healthy participants taking a
      CYP3A4 inhibitor (Part 2); to assess the safety and tolerability of multiple doses of BIIB091
      when administered as the selected BIIB091 regimen in healthy participants (Part 3).
    


Intervention name(s): BIIB091; Rabeprazole; Itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered as specified in the treatment arm; Administered as specified in the treatment arm; Administered as specified in the treatment arm
Intervention MeSH terms: Itraconazole; Rabeprazole
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment