A Randomised, Double-blind, Placebo-controlled, First Time-in-humans Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single, Escalating Doses of TA-8995 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature)
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of single doses of TA-8995 in healthy Caucasian and Japanese volunteers.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Caucasian men aged 18-55 years and ≥65 years
- •Women of non-childbearing potential
- •Japanese men aged 18-55 years
- •Subjects were deemed healthy on the basis of medical history, physical examination, Electrocardiogram (ECG), vital signs and safety tests of blood and urine
- •Subjects were able to give fully informed written consent
排除标准
- •HDL-C level ≥2.59 mmol/L
- •Abnormal Holter ECG
- •Family history of long QT syndrome, hypokalaemia or Torsade de Pointes
- •Vital signs or 12-lead ECG values outside the acceptable range
- •Positive tests for hepatitis B and C, HIV 1 and 2
- •Positive urine pregnancy test (women only)
- •Severe adverse reaction or allergy to any drug
- •Drug or alcohol abuse
- •Smoking within the 6 months before dosing with TA-8995 (Caucasian subjects), or smoking more than 10 cigarettes daily (Japanese subjects)
- •Over-the-counter or prescribed medication up to 7 days or 5 half-lives (whichever was longer) before dosing with TA-8995
- •Consuming food or drinks containing grapefruit or cranberry within the 7 days before dosing
- •Participation in other clinical trials, or loss of more than 450 mL blood within the previous 3 months
- •Clinically relevant abnormal findings at the screening assessment
- •Clinically relevant abnormal medical history or concurrent medical condition
- •Possibility that volunteer would not cooperate
研究组 & 干预措施
Placebo: Age-effect in Caucasian men
干预措施: Placebo (Drug)
Single ascending dose in Caucasian men
干预措施: TA-8995 (Drug)
Age-effect in Caucasian men
干预措施: TA-8995 (Drug)
Gender-effect in Caucasian women
干预措施: TA-8995 (Drug)
Single ascending dose in Japanese men
干预措施: TA-8995 (Drug)
Placebo: Single ascending dose in Caucasian men
干预措施: Placebo (Drug)
Placeo: Gender-effect in Caucasian women
干预措施: Placebo (Drug)
Placebo: Single ascending dose in Japanese men
干预措施: Placebo (Drug)
结局指标
主要结局
Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature)
时间窗: 336 hours post dose
Number of participants with adverse events
时间窗: 336 hours post dose
Laboratory tests (haematology, biochemistry and urinalysis)
时间窗: 336 hours post dose
Time of peak concentration (hr) of TA-8995
时间窗: 336 hours post dose
Area under the concentration-time curve (mg/L ・ hr) up to 24 h (AUC0-24), 72 h (AUC0-72), 168 h (AUC0-168), 336 h (AUC0-336) and infinity (AUC0-∞) of TA-8995
时间窗: 336 hours post dose
Peak concentration (ng/mL) of TA-8995
时间窗: 336 hours post dose
次要结局
- Plasma Cholesterol Ester Transfer Protein (CETP) activity (%) and concentration (mg/mL)(336 hours post dose)