NCT02521545已完成1 期
A Single-Dose Study in Healthy Volunteers to Assess the Pharmacokinetic Profile of a New Formulation of BIIB061
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- PK parameter - area under the concentration-time curve from time 0 to infinity (AUCinf)
研究概览
简要总结
The primary objective of the study is to assess the pharmacokinetic (PK) profile of BIIB061 in the new oral formulation in the fasted state in healthy male and female volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BIIB061 in the new formulation in this study population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and postmenopausal (defined as no menses for 12 months and confirmed by follicle-stimulating hormone [FSH] levels determined at screening to be in the postmenopausal range) or surgically sterile females.
- •All male subjects must practice effective contraception during the study and be willing and able to continue male contraception for 3 months after the dose of study treatment. All male subjects must also be willing to refrain from sperm donation for at least 3 months after their dose of study treatment.
- •Must be in good health and have normal vital signs as determined by the Investigator, based on medical history and screening evaluations.
- •Body mass index of 18.0 to 30.0 kg/m2, inclusive.
排除标准
- •History of or positive test result at screening for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
- •Prior exposure to BIIB
- •History of any clinically significant cardiac, endrocrinologic, hematologic, hepatic, gastric, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, oncologic, or other major disease, as determined by the Investigator.
- •Treatment with any prescription medication within 28 days prior to and throughout the duration of the study.
- •Use of any over-the-counter products, including herbal or alternative health preparations within the 14 days prior to the study
- •Enrollment in any interventional clinical study in which an investigational drug, biologic, device, or approved therapy for investigational use is administered or used within 30 days prior to the study
- •Any live or attenuated immunization/vaccination given within 30 days prior to the study or planned to be given during the study.
- •Blood donation within 30 days prior to the study
- •Surgery within 3 months prior to the study
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
BIIB061
Experimental
Single oral dose of 30 mg BIIB061 of the new formulation
干预措施: BIIB061 (Drug)
结局指标
主要结局
PK parameter - area under the concentration-time curve from time 0 to infinity (AUCinf)
时间窗: Day 1-4, 6, 10, 14, 21
PK parameter - AUC from time 0 to time of the last measurable concentration (AUClast)
时间窗: Day 1-4, 6, 10, 14, 21
PK parameter - maximum observed concentration (Cmax)
时间窗: Day 1-4, 6, 10, 14, 21
次要结局
- PK parameter - Time to reach maximum observed concentration (Tmax)(Day 1-4, 6, 10, 14, 21)
- PK parameter - half-life (t1/2)(Day 1-4, 6, 10, 14, 21)
- Incidence of adverse events (AEs) and serious adverse events (SAEs)(Up to 21 days)
- Assessment of changes from baseline in Clinical laboratory parameters(Up to 21 days)
- Assessment of clinically relevant abnormalities in Vital signs(Up to 21 days)
- Assessment of physical examinations(Up to 21 days)
研究者
研究点 (1)
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