The primary objectives of the study are to assess the relative bioavailability of the BIIB074 direct compression formulation (DCF) to the BIIB074 roller compaction formulation (RCF) and to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the BIIB074 DCF. The secondary objective of the study is to assess the safety and tolerability of BIIB074 administered as the DCF following single oral dose administration in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
28
Lower dose RCF fasted
Lower dose DCF fasted
Higher dose DCF fasted
Research Site
Daytona Beach, Florida, United States
PK of BIIB074 DCF to RCF as assessed by maximum observed concentration (Cmax)
Time frame: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF to RCF as assessed by area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUClast)
Time frame: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF to RCF as assessed by AUC from time 0 to infinity (AUC∞)
Time frame: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF as assessed by Cmax
Time frame: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF as assessed by AUClast
Time frame: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF as assessed by AUC∞
Time frame: Day 1, 2, 3, 8, 9, 10
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 18
Number of participants with clinically significant laboratory assessment abnormalities
Time frame: Up to Day 10
Number of participants with clinically significant vital sign abnormalities
Time frame: Up to Day 10
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time frame: Up to Day 10
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Higher dose DCF fed
Number of participants with clinically significant physical examinations abnormalities
Time frame: Up to Day 10