Pharmacokinetics, Safety, and Tolerability Study of Multiple Oral Doses of Verducatib for 4 Weeks in Healthy Chinese Male and Female Trial Participants (Open-label, Single Arm)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
研究概览
简要总结
To assess pharmacokinetics, safety, and tolerability of multiple oral doses of verducatib in healthy Chinese male and female trial participants in order to facilitate the clinical development of verducatib in China.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female trial participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 55 years (inclusive)
- •BMI of 18.5 to 28 kg/m2 (inclusive)
- •Signed and dated written informed consent in accordance with International Council on Harmonization - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- •Further inclusion criteria apply
排除标准
- •Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- •Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 100 beats per minute (bpm)
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- •Further exclusion criteria apply
研究组 & 干预措施
Verducatib treatment
干预措施: Verducatib (Drug)
结局指标
主要结局
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ (Cmax,ss)
时间窗: Up to Day 64
Area under the concentration-time curve of the analyte in plasma from time point 0 to time point 24 h after administration of the first dose (AUC0-24)
时间窗: At 24 hours
Maximum measured concentration of the analyte in plasma after administration of the first dose (Cmax)
时间窗: At 24 hours
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ (AUCτ,ss)
时间窗: Up to Day 64
次要结局
- Occurrence of treatment emergent adverse events during the trial(Up to Day 65)