A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Single or Multiple Oral Doses of ABSK061 Mini-tablets and to Evaluate the Effect of Soft Food With ABSK061 Mini-tablets on Its Pharmacokinetic Profile in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pharmacokinetics single-dose Cmax
研究概览
简要总结
To main objective is to evaluate the safety, tolerability, and pharmacokinetic profile of single or multiple oral doses of ABSK061 mini-tablets and to evaluate the effect of soft food with ABSK061 mini-tablets on its pharmacokinetic profile in healthy adult 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
- None
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
- •Gender:male or female participants, both male and female
- •Age: 18 to 45 years (including 18 and 45 years)
- •Weight: male participants weigh ≥ 50.0 kg, female participants weigh ≥ 45.0 kg, and body mass index is in the range of 19.0-26.0 kg/m2 (including cut-off value), and body mass index (BMI) = weight (kg)/height 2 (m2)
- •Able to understand and willing to comply with the study procedures, voluntarily participate in this clinical trial and sign the informed consent form before screening
排除标准
- •Significant history of any hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, musculoskeletal disease, or allergic disease (as determined by the Investigator)
- •Any ocular condition likely to increase the risk of eye toxicity
- •Gastrointestinal disorders that will affect oral administration or absorption of ABSK061
- •Females of child-bearing potential and males who plan to father a child while enrolled in this study
研究组 & 干预措施
Food Effect on ABSK061
Food Effect Tablet Formulation
干预措施: ABSK061 (Drug)
Multiple oral doses of ABSK061
The safety, tolerability, and PK profile of multiple oral doses of ABSK061
干预措施: ABSK061 (Drug)
Single oral dose of ABSK061
Pharmacokinetic profile (PK) and safety of a single oral dose
干预措施: ABSK061 (Drug)
结局指标
主要结局
Pharmacokinetics single-dose Cmax
时间窗: Up to 48 hours post-dose
maximum plasma concentration (Cmax)
Pharmacokinetics multiple-dose Cmax
时间窗: Up to 24 hours post-dose
maximum steady-state plasma concentration (Cmax)
Pharmacokinetics multiple-dose Cmin
时间窗: Up to 24 hours post-dose
average steady-state trough plasma concentration (Cmin)
Pharmacokinetics single dose Tmax
时间窗: Up to 48 hours post-dose
time to reach maximum plasma concentration (Tmax)
Pharmacokinetics single and multiple dose AUC
时间窗: Up to 48 hours post-dose
area under the plasma concentration-time curve (AUC)
Pharmacokinetics multiple-dose RAUC
时间窗: Up to 24 hours post-dose
accumulation ratio for AUC
Pharmacokinetics multiple-dose RCmax
时间窗: Up to 24 hours post-dose
accumulation ratio for Cmax (RCmax)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: Initiation of study treatment up to 18-days post treatment
number of participants with adverse events (AEs), serious adverse events (SAEs), as a measure of safety and tolerability
Number of participants with abnormal laboratory tests results and abnormal physical exam findings
时间窗: Initiation of study treatment up to 18-days post treatment
Frequency in changes in laboratory parameters and physical signs of toxicity
次要结局
- Pharmacokinetics single dose CL/F(Up to 48 hours post-dose)
- Pharmacokinetics single dose Vz/F(Up to 48 hours post-dose)
- Pharmacokinetics single dose t1/2(Up to 48 hours post-dose)