A Randomized, Open-Label, Six-Sequence, Three-Period Crossover Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration of Separate Tablets of K-877-ER Plus CSG452 in Healthy Adult Volunteers, and to Characterize the Food Effect on the Pharmacokinetics of K-001
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cmax of K-877 and CSG452
研究概览
简要总结
The goal of this clinical trial is to demonstrate the bioequivalence of single oral administration of K-001 relative to single oral co-administration of separate tablets of K-877-ER and CSG452 in healthy adult volunteers, and to characterize the food effect on the Pharmacokinetics(PK) of K-001.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant provides written informed consent before any study-specific evaluation is performed.
- •Participant is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
- •Participant has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
- •Participant meet all other inclusion criteria outlined in the clinical study protocol.
排除标准
- •Participant has clinically significant abnormalities at Screening or at Check-in assessments, in the opinion of the investigator.
- •Participant is pregnant or breastfeeding or intends to become pregnant within 30 days after the last dose of study drug.
- •Participant meets any other exclusion criteria outlined in the clinical study protocol.
研究组 & 干预措施
Sequence B
Three period alternative intervention and fed/fasted sequence
干预措施: K-877-ER (Drug)
Sequence B
Three period alternative intervention and fed/fasted sequence
干预措施: K-001 (Drug)
Sequence A
Three period alternative intervention and fed/fasted sequence
干预措施: K-001 (Drug)
Sequence A
Three period alternative intervention and fed/fasted sequence
干预措施: K-877-ER (Drug)
Sequence A
Three period alternative intervention and fed/fasted sequence
干预措施: CSG452 (Drug)
Sequence B
Three period alternative intervention and fed/fasted sequence
干预措施: CSG452 (Drug)
Sequence C
Three period alternative intervention and fed/fasted sequence
干预措施: K-001 (Drug)
Sequence C
Three period alternative intervention and fed/fasted sequence
干预措施: K-877-ER (Drug)
Sequence C
Three period alternative intervention and fed/fasted sequence
干预措施: CSG452 (Drug)
Sequence D
Three period alternative intervention and fed/fasted sequence
干预措施: K-001 (Drug)
Sequence D
Three period alternative intervention and fed/fasted sequence
干预措施: K-877-ER (Drug)
Sequence D
Three period alternative intervention and fed/fasted sequence
干预措施: CSG452 (Drug)
Sequence E
Three period alternative intervention and fed/fasted sequence
干预措施: K-001 (Drug)
Sequence E
Three period alternative intervention and fed/fasted sequence
干预措施: K-877-ER (Drug)
Sequence E
Three period alternative intervention and fed/fasted sequence
干预措施: CSG452 (Drug)
Sequence F
Three period alternative intervention and fed/fasted sequence
干预措施: K-001 (Drug)
Sequence F
Three period alternative intervention and fed/fasted sequence
干预措施: K-877-ER (Drug)
Sequence F
Three period alternative intervention and fed/fasted sequence
干预措施: CSG452 (Drug)
结局指标
主要结局
Cmax of K-877 and CSG452
时间窗: 1 hour before dosing and at multiple time points (up to 48 hours) post dose
Maximum observed plasma concentration (Cmax) of K-877 and CSG452
AUC0-t of K-877 and CSG452
时间窗: 1 hour before dosing and at multiple time points (up to 48 hours) post dose
Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)
AUC0-inf of K-877-and CSG452
时间窗: 1 hour before dosing and at multiple time points (up to 48 hours) post dose
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf).
次要结局
未报告次要终点