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/ / 257HV105
Study of BIIB091 Formulations in Healthy Participants
PLS AVAILABLE
Study Identifier257HV105
Clinicaltrials.gov
#NCT04564612
Details
Development Status
In Development
Study Type
Interventional
Results Available
Yes
Study Dates
09/2020 - 09/2022
Enrollment
59
Study Drug
BIIB091, rabeprazole, itraconazole
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 ass...
Study Results
View and download the Results Summaries with the results of this completed study.
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Plain Language Summary
PDF Document