A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB068, a Bruton's Tyrosine Kinase Inhibitor, in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Number of participants with clinically significant Vital sign abnormalities
研究概览
简要总结
The primary objective of the study is to evaluate the safety and tolerability of single oral doses of BIIB068 in healthy participants. Secondary objectives are to characterize the single-oral-dose Pharmacokinetic (PK) of BIIB068 in healthy participants, to determine the effect of food on the single-oral-dose PK of BIIB068 in healthy participants and to examine the effect of administration of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of BIIB068 in healthy 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
- Double (Participant, Investigator)
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
- •All male subjects must practice highly effective methods of contraception during the study and be willing and able to continue contraception and not donate sperm for at least 1 spermatogenic cycle (90 days) after administration of last dose of study treatment.
- •All female subjects of childbearing potential must practice highly effective methods of contraception during the study and be willing and able to continue contraception for at least 1ovulatory cycle (30 days) after their last dose of study treatment.
- •Must have a body mass index (BMI) between 18 and 32 kg/m2
- •Must be in good health as determined by the Investigator, based on medical history and screening evaluations.
排除标准
- •History of any clinically significant cardiac, endocrine, gastrointestinal (GI), hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
- •History of severe allergic or anaphylactic reactions, or history of any allergic reactions that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
- •Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day-
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Cohorts 1
6 participants randomized (4:2) to receive a single-ascending dose (SAD) administered orally in tablet
干预措施: BIIB068 (Drug)
Cohorts 1
6 participants randomized (4:2) to receive a single-ascending dose (SAD) administered orally in tablet
干预措施: Placebo (Drug)
Cohort 2
6 participants randomized (4:2) to receive a SAD administered orally in tablet(s)
干预措施: BIIB068 (Drug)
Cohort 2
6 participants randomized (4:2) to receive a SAD administered orally in tablet(s)
干预措施: Placebo (Drug)
Cohort 3
8 participants randomized (6:2) to receive a SAD administered orally in tablet(s)
干预措施: BIIB068 (Drug)
Cohort 3
8 participants randomized (6:2) to receive a SAD administered orally in tablet(s)
干预措施: Placebo (Drug)
Cohort 4
8 participants randomized (6:2) to receive a SAD administered orally in tablet
干预措施: BIIB068 (Drug)
Cohort 4
8 participants randomized (6:2) to receive a SAD administered orally in tablet
干预措施: Placebo (Drug)
Cohort 5
8 participants randomized (6:2) to receive a SAD administered orally in tablet(s)
干预措施: BIIB068 (Drug)
Cohort 5
8 participants randomized (6:2) to receive a SAD administered orally in tablet(s)
干预措施: Placebo (Drug)
Cohort 6
14 participants (all active) to receive a SAD administered orally in tablet(s)
干预措施: BIIB068 (Drug)
结局指标
主要结局
Number of participants with clinically significant Vital sign abnormalities
时间窗: Up to 9 Days Post dose
Number of participants with clinically significant laboratory assessment abnormalities
时间窗: Up to 9 Days Post dose
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Up to 9 Days Post dose
Number of participants with clinically significant physical examination abnormalities
时间窗: Up to 9 Days Post dose
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
时间窗: Up to 9 Days Post dose
次要结局
- PK Assessment - Time to reach maximum observed concentration (Tmax)(Up to 48 Hours Post dose)
- PK Assessment - Terminal elimination half-life (t1/2)(Up to 48 Hours Post dose)
- PK Assessment - Apparent volume of distribution (Vz/F)(Up to 48 Hours Post dose)
- PK Assessment - Amount of BIIB068 excreted in urine (Aeu)(Up to 48 Hours Post dose)
- PK Assessment - Area under the concentration-time curve from time 0 to infinity (AUCinf)(Up to 48 Hours Post dose)
- PK Assessment - Apparent total body clearance (CL/F)(Up to 48 Hours Post dose)
- PK Assessment - Percentage (%fe) of BIIB068 excreted in urine(Up to 48 Hours Post dose)
- PK Assessment - Renal clearance (CLr)(Up to 48 Hours Post dose)
- PK Assessment - Maximum observed concentration (Cmax)(Up to 48 Hours Post dose)
- PK Assessment - Area Under the concentration-time curve from time zero to time of the Last Measurable Concentration (AUC0-tlast)(Up to 48 Hours Post dose)