A Phase 1, Open-label Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB074 and to Assess the Effect of Food on BIIB074 Pharmacokinetics in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- PK of BIIB074 DCF as assessed by AUClast
研究概览
简要总结
The primary objectives of the study are to assess the relative bioavailability of the BIIB074 direct compression formulation (DCF) to the BIIB074 roller compaction formulation (RCF) and to determine the effect of a high-fat meal on the pharmacokinetics (PK) of the BIIB074 DCF. The secondary objective of the study is to assess the safety and tolerability of BIIB074 administered as the DCF following single oral dose administration in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have a body mass index between 18 and 30 kg/m2, inclusive.
- •Must be in good health as determined by the Investigator, based on medical history and screening evaluations.
- •Ability to consume and tolerate the entire high-fat breakfast within a 30-minute timeframe.
排除标准
- •History of, or positive test result at Screening for, human immunodeficiency virus (HIV).
- •Positive test result at Screening for hepatitis C virus antibody.
- •Positive test result at Screening for hepatitis B virus (defined as positive for hepatitis B surface antigen and/or hepatitis B core antibody).
- •Previous exposure to BIIB
- •Consumption of xanthine/caffeine-containing products (e.g., energy drinks, coffee, tea, caffeinated soda) within 48 hours of Day -1 and an unwillingness to refrain from product use during study participation.
- •History of alcohol or substance abuse (as determined by the Investigator), a positive urine drug screen or alcohol breath test at Screening or Day -1, or an unwillingness to refrain from alcohol, or illicit or recreational drugs, during the study.
- •History or evidence of habitual use of tobacco- or nicotine-containing products within 90 days of Screening, or a positive cotinine screen at Screening or Day -
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Cohort 1
Treatment sub groups A and B
干预措施: BIIB074 Treatment A (Drug)
Cohort 1
Treatment sub groups A and B
干预措施: BIIB074 Treatment B (Drug)
Cohort 2
Treatment sub groups C and D
干预措施: BIIB074 Treatment C (Drug)
Cohort 2
Treatment sub groups C and D
干预措施: BIIB074 Treatment D (Drug)
结局指标
主要结局
PK of BIIB074 DCF as assessed by AUClast
时间窗: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF to RCF as assessed by maximum observed concentration (Cmax)
时间窗: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF to RCF as assessed by area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUClast)
时间窗: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF to RCF as assessed by AUC from time 0 to infinity (AUC∞)
时间窗: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF as assessed by Cmax
时间窗: Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF as assessed by AUC∞
时间窗: Day 1, 2, 3, 8, 9, 10
次要结局
- Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities(Up to Day 10)
- Number of participants with clinically significant physical examinations abnormalities(Up to Day 10)
- Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to Day 18)
- Number of participants with clinically significant laboratory assessment abnormalities(Up to Day 10)
- Number of participants with clinically significant vital sign abnormalities(Up to Day 10)