Clinical trial NCT05148481: A Study to Evaluate Safety and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2021-12-08
Enrollment: 31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Key Inclusion Criteria:

* Have a body mass index between 18 and 30 kilograms per meter square (kg/m\^2), inclusive, and total body weight \>50 kilograms (kg) \[110 pounds (lb)\].
* For Japanese participants, was born in Japan, and biological parents and grandparents were of Japanese origin.
* For Japanese participants, if living outside Japan for more than 5 years, must not have significantly modified diet since leaving Japan.
* Non-Japanese participants must have a screening weight within ±20% of the mean value for Japanese participants.

Key Exclusion Criteria:

* Participation in other studies involving treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to randomization and/or during study participation.
* History of severe allergic or anaphylactic reactions, systemic hypersensitivity reaction to BIIB104, or any allergic reactions that in the opinion of the investigator are likely to be exacerbated by any component of the study treatment.
* History of seizures or a condition with risk of seizures.
* History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
* Chronic, recurrent, or serious infection, as determined by the investigator, within 6 months prior to screening or between screening and Day 1.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Maximum Observed Concentration (Cmax) of BIIB104
timeFrame: Up to Day 11
measure: Time to Reach Maximum Observed Concentration (Tmax) of BIIB104
timeFrame: Up to Day 11
measure: Area Under the Concentration-Time Curve Within a Dosing Interval for Single Dose [AUC(tau,sd)] of BIIB104
timeFrame: Up to Day 11
measure: Maximum Observed Concentration at Steady State (Cmax,ss) of BIIB104
timeFrame: Up to Day 11
measure: Time to Reach Maximum Observed Concentration at Steady State (Tmax,ss) of BIIB104
timeFrame: Up to Day 11
measure: Area Under the Concentration-Time Curve Over a Uniform Dosing Interval Tau at Steady State [AUC(tau,ss)] of BIIB104
timeFrame: Up to Day 11
measure: Apparent Total Body Clearance (CL/F) of BIIB104
timeFrame: Up to Day 11
measure: Apparent Volume of Distribution (Vz/F) of BIIB104
timeFrame: Up to Day 11
measure: Elimination Half-Life (t½) of BIIB104
timeFrame: Up to Day 11
measure: Accumulation Ratio for Steady State of BIIB104
timeFrame: Up to Day 11
measure: Trough Concentration (Ctrough) of BIIB104
timeFrame: Up to Day 11
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Day 1 up to Day 25
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: From screening up to Day 25
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Research Site
state: California
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: