The primary objective of the study is to assess the pharmacokinetic (PK) profile of BIIB061 in the new oral formulation in the fasted state in healthy male and female volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in the new formulation in this study population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Capsule
Research Site
Madison, Wisconsin, United States
PK parameter - area under the concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Day 1-4, 6, 10, 14, 21
PK parameter - AUC from time 0 to time of the last measurable concentration (AUClast)
Time frame: Day 1-4, 6, 10, 14, 21
PK parameter - maximum observed concentration (Cmax)
Time frame: Day 1-4, 6, 10, 14, 21
PK parameter - Time to reach maximum observed concentration (Tmax)
Time frame: Day 1-4, 6, 10, 14, 21
PK parameter - half-life (t1/2)
Time frame: Day 1-4, 6, 10, 14, 21
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 21 days
Assessment of changes from baseline in Clinical laboratory parameters
Time frame: Up to 21 days
Assessment of clinically relevant abnormalities in Vital signs
Time frame: Up to 21 days
Assessment of physical examinations
Time frame: Up to 21 days
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