A Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1473 in Healthy Adult Japanese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve (AUC0 t)
研究概览
简要总结
A Phase 1, double blind, placebo controlled, 4 cohort, multiple dose study in healthy adult Japanese and Caucasian subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- All
- 接受健康志愿者
- 是
入选标准
- •For All subjects:
- •Male or female between 18 to 55 years old
- •Female subjects must have documentation of a negative serum pregnancy test,
- •Female subjects must be either of non-childbearing potential or if of childbearing potential use a highly efficient birth control method
- •Male subjects must be vasectomized with documented medical assessment of the surgical success, or use acceptable contraception
- •All male subjects must agree to refrain from sperm donation during the study and for at least 7 days after the last dose of study drug.
- •Body Mass Index (BMI) 18 to 32 kg/m2, inclusive, and weighs at least 50 kg and less than 90 kg
- •Willing and able to give informed consent
- •Additional inclusion criteria apply
- •For Japanese subjects only:
- •Subject must have been born in Japan, with 2 Japanese biological parents and 4 Japanese grandparents as confirmed by interview.
- •Subject has lived no longer than 10 years outside of Japan.
- •Subject had no significant change in lifestyle, including diet, since leaving Japan.
- •For Caucasian subjects only:
- •Subject has 2 Caucasian biological parents and 4 Caucasian grandparents as confirmed by interview.
- •Subject has lived no longer than 10 years outside of Europe and/or North America.
排除标准
- •For all subjects:
- •Subject is a female who is pregnant, lactating, breastfeeding, or planning to become pregnant during the study or within 7 days after the last dose of study drug.
- •Subject is a male who is planning to father a child during the study or within 7 days after the last dose of study drug.
- •Is positive for hepatitis A, B or C, and/or HIV
- •Has clinically significant abnormalities in baseline laboratory evaluations
- •Subject has a clinically significant abnormal electrocardiogram (ECG)
- •Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to screening or is currently participating in another trial of an investigational drug (or medical device) Additional exclusion criteria apply
研究组 & 干预措施
Cohort 3
Caucasian subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Caucasian subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
干预措施: Placebo (Drug)
Cohort 1
Japanese subjects will receive oral doses of either TD-1473 - Dose A or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
干预措施: TD-1473 - Dose A (Drug)
Cohort 1
Japanese subjects will receive oral doses of either TD-1473 - Dose A or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
干预措施: Placebo (Drug)
Cohort 4
Japanese subjects will receive oral doses of either TD-1473 - Dose C or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
干预措施: TD-1473 - Dose C (Drug)
Cohort 2
Japanese subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
干预措施: TD-1473 - Dose B (Drug)
Cohort 2
Japanese subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
干预措施: Placebo (Drug)
Cohort 3
Caucasian subjects will receive oral doses of either TD-1473 - Dose B or placebo (15 healthy Caucasian subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
干预措施: TD-1473 - Dose B (Drug)
Cohort 4
Japanese subjects will receive oral doses of either TD-1473 - Dose C or placebo (15 healthy Japanese subjects randomized 3:1 to 12 active and 3 placebo) once daily (QD) for 14 consecutive days.
干预措施: Placebo (Drug)
结局指标
主要结局
Area under the concentration-time curve (AUC0 t)
时间窗: Day 1 & Day 14
Area under the concentration-time curve (AUCtau)
时间窗: Day 1 & Day 14
Maximum observed concentration (Cmax)
时间窗: Day 1 & Day 14
Area under the concentration-time curve (AUC0 24)
时间窗: Day 1 & Day 14
Maximum observed concentration at steady state (Cmax_ss)
时间窗: Day 1 & Day 14
次要结局
未报告次要终点