A Single and Multiple Dose, Open-Label Study of the Pharmacokinetics, Safety, and Tolerability of Dexpramipexole (BIIB050) in Healthy Japanese and Caucasian Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Cmax of dexpramipexole
研究概览
简要总结
This is a single and multiple dose, open-label study to evaluate the pharmacokinetics (PK), safety, and tolerability of dexpramipexole administered orally to adult Japanese and Caucasian healthy subjects.
详细描述
The study is designed to evaluate the influence of ethnic factors on dexpramipexole safety, tolerability, and PK. Subjects will be admitted to the clinical unit on Day -1 (the day prior to first dosing) and will remain in the clinical unit under observation until discharge. All subjects will have a final follow up visit. Whilst resident in the clinic, subjects will receive 4 treatments: The first 3 treatments comprise Part A of the study and the final treatment group comprises Part B.
Part A:
Treatment 1: Dose 1 (reduced) of dexpramipexole; a single dose Treatment 2: Dose 2 (standard) dexpramipexole; a single dose Treatment 3: Dose 3 (standard) dexpramipexole; 5 doses administered at 12 hour intervals Part B: Dose 4 (standard) dexpramipexole; 5 doses administered at 12 hour intervals There will be a minimum washout of 3 days between treatments.
For all subjects, prior to proceeding to the next treatment group, safety and tolerability data will be reviewed.
Caucasian subjects will be matched individually (on a 1:1 basis) to Japanese subjects with respect to gender and age and if possible BMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who are able and willing to give written informed consent.
- •Adult Japanese and Caucasian males/females aged 18 to 60 years inclusive and between 18 and 30 kg/m2 body mass index (BMI), inclusive.
- •Male and female subjects will be enrolled on the study. Male subjects and female subjects of childbearing potential, must practice effective contraception during the study and be willing and able to continue contraception for 1 month (females) or 3 months (males) after their last dose of study treatment
- •Japanese subjects must be born in Japan and have both parents and four grandparents of Japanese descent.
- •Japanese subjects must have lived outside of Japan for no more than 5 years.
- •Japanese subjects must not have significant changes with regard to diet; i.e., their diet must not have significantly changed since leaving Japan.
- •Caucasian subjects will be matched individually (on a 1:1 basis) to Japanese subjects with respect to gender and age, and if possible BMI.
排除标准
- •Subjects who do not conform to the above inclusion criteria.
- •Female subjects who are pregnant, trying to become pregnant or lactating.
- •Subjects who have a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders.
- •Subjects who have a clinically relevant surgical history.
- •Subjects who have previously received dexpramipexole or pramipexole.
研究组 & 干预措施
Treatment for Part B
Dexpramipexole multiple dosing
干预措施: Multiple Dose (Drug)
Treatment 1 (Part A)
Dexpramipexole single dose (reduced dose)
干预措施: Single dose reduced (Drug)
Treatment 2 (Part A)
Dexpramipexole single dose (Standard dose)
干预措施: Single dose standard (Drug)
Treatment 3 (Part A)
Dexpramipexole multiple dosing
干预措施: Multiple Dose (Drug)
结局指标
主要结局
Cmax of dexpramipexole
时间窗: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours after dosing on Days 1 and 5 in Treatments 1 and 2, and after the fifth dose on Day 11 in Treatment 3 for Parts A & B.
AUC of dexpramipexole
时间窗: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, and 72 hours after dosing on Days 1 and 5 in Treatments 1 and 2, and after the fifth dose on Day 11 in Treatment 3 for Parts A & B.
次要结局
- ECG changes(pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose))
- Vital Sign changes(pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose))
- Adverse Event monitoring(pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose))
- Changes in clinical laboratory tests(pre-dose to 72 hrs post-dose in each dose group and again at follow-up (14 hrs post last dose))