A Randomised Double-blind, Placebo-controlled, Ascending-dose, Phase I Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 After Multiple Doses in Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration (AUC) versus time curve over the final dosing interval (AUC0-τ, Steady-state)
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of TA-8995 after multiple doses in healthy adult male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Free from any clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests and as judged by the Investigator.
- •Between 18 - 55 years old.
- •Male of Caucasian ethnic origin.
- •Body mass index (BMI) in the range of 19 - 33 kg/m² and had a minimum weight of 50 kg. Subjects with a BMI in the range 30.0 - 33.0 kg/m² had to have a waist measurement of ≤ 91 cm.
排除标准
- •High density lipoprotein (HDL)-C level of greater or equal to 2.59 mmol/L (≥ 100 mg/dL) at Screening.
- •Abnormal Electrocardiogram (ECG) at Screening or Day -1 including a QTc ≥ 430 ms (The QTc-interval was calculated automatically according to Bazett's formula. In the case of results of ≥ 430 ms, QTc was additionally calculated manually using Fridericia's formula which was used as an exclusion criterion).
- •Family history of long QT syndrome, hypokalaemia or Torsades de Pointes
- •Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease or history of any psychotic illness
- •Presence or history of gastro-intestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
研究组 & 干预措施
TA-8995 5 mg
干预措施: TA-8995 (Drug)
TA-8995 1 mg
干预措施: TA-8995 (Drug)
TA-8995 2.5 mg
干预措施: TA-8995 (Drug)
TA-8995 10 mg
干预措施: TA-8995 (Drug)
TA-8995 25 mg
干预措施: TA-8995 (Drug)
Placebo (TA-8995 1mg)
干预措施: Placebo (Drug)
Placebo (TA-8995 2.5mg)
干预措施: Placebo (Drug)
Placebo (TA-8995 5mg)
干预措施: Placebo (Drug)
Placebo (TA-8995 10mg)
干预措施: Placebo (Drug)
Placebo (TA-8995 25mg)
干预措施: Placebo (Drug)
结局指标
主要结局
Area under the plasma concentration (AUC) versus time curve over the final dosing interval (AUC0-τ, Steady-state)
时间窗: 7 days post the final dose
Number of participants with adverse events
时间窗: 336 hours post dose
Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature)
时间窗: 336 hours post dose
Laboratory tests (haematology, biochemistry and urinalysis)
时间窗: 336 hours post dose
The last time point 't' with a concentration Ct ≥ Lower limit quantification (LLQ) (AUC0-t, Steady-state)
时间窗: 7 days post the final dose
次要结局
- CETP concentration (mg/mL)(4 hours after the first and the fibal dose)
- Cholesterol ester transfer protein (CETP) activity (%)(7 days post the final dose)