Study of BIIB091 Formulations in Healthy Participants
Status:
Recruiting
Trial end date:
2022-05-07
Target enrollment:
Participant gender:
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).