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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Time to Reach Maximum Observed Concentration (Tmax) of BIIB104
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
BIIB104: Dose 1
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.
干预措施: BIIB104 (Drug)
BIIB104: Dose 2
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.
干预措施: BIIB104 (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Reach Maximum Observed Concentration (Tmax) of BIIB104
时间窗: Up to Day 11
Maximum Observed Concentration (Cmax) of BIIB104
时间窗: Up to Day 11
Maximum Observed Concentration at Steady State (Cmax,ss) of BIIB104
时间窗: Up to Day 11
Time to Reach Maximum Observed Concentration at Steady State (Tmax,ss) of BIIB104
时间窗: Up to Day 11
Apparent Total Body Clearance (CL/F) of BIIB104
时间窗: Up to Day 11
Apparent Volume of Distribution (Vz/F) of BIIB104
时间窗: Up to Day 11
Accumulation Ratio for Steady State of BIIB104
时间窗: 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
时间窗: Up to Day 11
Area Under the Concentration-Time Curve Over a Uniform Dosing Interval Tau at Steady State [AUC(tau,ss)] of BIIB104
时间窗: Up to Day 11
Elimination Half-Life (t½) of BIIB104
时间窗: Up to Day 11
Trough Concentration (Ctrough) of BIIB104
时间窗: Up to Day 11
次要结局
- Number of Participants with Adverse Events (AEs)(Day 1 up to Day 25)
- Number of Participants with Serious Adverse Events (SAEs)(From screening up to Day 25)