A Study to Evaluate Safety and Pharmacokinetics of BIIB104 in Healthy Japanese and Non-Japanese Participants
- Registration Number
- NCT05148481
- Lead Sponsor
- Biogen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 31
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Japanese and non-Japanese participants will receive BIIB104-matching placebo, oral capsule, BID, from Day 1 through Day 9 with an additional dose on Day 10. BIIB104: Dose 1 BIIB104 Japanese and non-Japanese participants will receive BIIB104, Dose 1, oral capsule, BID, from Day 1 through Day 9 with an additional dose on Day 10. BIIB104: Dose 2 BIIB104 Japanese and non-Japanese participants will receive BIIB104, Dose 2, oral capsule, BID, from Day 1 through Day 9 with an additional dose on Day 10.
- Primary Outcome Measures
Name Time Method Trough Concentration (Ctrough) of BIIB104 Up to Day 11 Time to Reach Maximum Observed Concentration (Tmax) of BIIB104 Up to Day 11 Maximum Observed Concentration (Cmax) of BIIB104 Up to Day 11 Maximum Observed Concentration at Steady State (Cmax,ss) of BIIB104 Up to Day 11 Time to Reach Maximum Observed Concentration at Steady State (Tmax,ss) of BIIB104 Up to Day 11 Apparent Total Body Clearance (CL/F) of BIIB104 Up to Day 11 Apparent Volume of Distribution (Vz/F) of BIIB104 Up to Day 11 Accumulation Ratio for Steady State of BIIB104 Up to Day 11 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 \[AUC(tau,ss)/AUC(tau,sd)\].
Area Under the Concentration-Time Curve Within a Dosing Interval for Single Dose [AUC(tau,sd)] of BIIB104 Up to Day 11 Area Under the Concentration-Time Curve Over a Uniform Dosing Interval Tau at Steady State [AUC(tau,ss)] of BIIB104 Up to Day 11 Elimination Half-Life (t½) of BIIB104 Up to Day 11
- Secondary Outcome Measures
Name Time Method Number of Participants with Adverse Events (AEs) Day 1 up to Day 25 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.
Number of Participants with Serious Adverse Events (SAEs) From screening up to Day 25 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.
Trial Locations
- Locations (1)
Research Site
🇺🇸Anaheim, California, United States