The primary objective of the study is to evaluate the pharmacokinetics (PK) of BIIB104 in healthy Japanese and non-Japanese participants. The secondary objective of the study is to evaluate the safety and tolerability of multiple, oral doses of BIIB104 administered twice daily (BID) for 9 days, with an additional dose occurring in the morning on Day 10 in healthy Japanese and non-Japanese participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
31
Research Site
Anaheim, California, United States
Maximum Observed Concentration (Cmax) of BIIB104
Time frame: Up to Day 11
Time to Reach Maximum Observed Concentration (Tmax) of BIIB104
Time frame: Up to Day 11
Area Under the Concentration-Time Curve Within a Dosing Interval for Single Dose [AUC(tau,sd)] of BIIB104
Time frame: Up to Day 11
Maximum Observed Concentration at Steady State (Cmax,ss) of BIIB104
Time frame: Up to Day 11
Time to Reach Maximum Observed Concentration at Steady State (Tmax,ss) of BIIB104
Time frame: Up to Day 11
Area Under the Concentration-Time Curve Over a Uniform Dosing Interval Tau at Steady State [AUC(tau,ss)] of BIIB104
Time frame: Up to Day 11
Apparent Total Body Clearance (CL/F) of BIIB104
Time frame: Up to Day 11
Apparent Volume of Distribution (Vz/F) of BIIB104
Time frame: Up to Day 11
Elimination Half-Life (t½) of BIIB104
Time frame: Up to Day 11
Accumulation Ratio for Steady State of BIIB104
Accumulation ratio for steady state is defined as area under the concentration-time curve over a uniform dosing interval tau at steady state divided by area under the concentration-time curve within a dosing interval for single dose \[AUC(tau,ss)/AUC(tau,sd)\].
Time frame: Up to Day 11
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Trough Concentration (Ctrough) of BIIB104
Time frame: Up to Day 11
Number of Participants with Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: Day 1 up to Day 25
Number of Participants with Serious Adverse Events (SAEs)
A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, in the view of the investigator, places the participant at immediate risk of death (a life-threatening event), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect or is a medically important event.
Time frame: From screening up to Day 25