NCT01655771已完成1 期
A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Assess the Safety, Tolerability, and Pharmacokinetics of TD-1211 Administered Orally to Elderly and Young Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- AUCt
研究概览
简要总结
The purpose of this study is to measure the way in which TD-1211 is absorbed and eliminated by the body and to evaluate whether it is safe and well tolerated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For the elderly cohort, nonsmoking 65 to 85 years, inclusive. For the young cohort, nonsmoking 18 to 45 years, inclusive.
- •Body mass index (BMI) should be 18 to 36 kg/m2, inclusive.
- •At screening, sitting or supine heart rate of 50 to 100 beats per minute and sitting or supine systolic and diastolic blood pressure of 90 to 150 mm Hg and 50 to 90 mm Hg, respectively (2 of 3 measurements)
- •Subjects with mild, chronic, stable disease (e.g., controlled hypertension, non-insulin-dependent diabetes, arthritis) may be enrolled if deemed medically acceptable by the investigator
- •Negative for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus antibody within the last 3 months
- •No clinically relevant abnormalities in laboratory evaluations
排除标准
- •History or presence of clinically significant respiratory, gastrointestinal, renal, hepatic, endocrine, hematological, neurological (including chronic headache, current or prior psychiatric disease/condition, stroke), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, or dermatological disorders. Subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non insulin-dependent diabetes, osteoarthritis) may be enrolled if condition is well controlled and not anticipated to interfere with the objectives of the study.
- •Any clinically significant abnormal ECG (electrocardiogram).
- •Participation in another clinical trial of an investigational drug or medical device within 60 days.
- •Donation of ≥500 mL blood, or equivalent, within 8 weeks prior to admission day.
- •Any other condition that, in the opinion of the investigator, would confound or interfere with evaluation of safety, tolerability, or PK of the investigational drug or prevent compliance with the study protocol.
研究组 & 干预措施
Elderly
Experimental
TD-1211 Dose 1
干预措施: TD-1211 Dose 1 (Drug)
Younger
Experimental
TD-1211 Dose 2
干预措施: TD-1211 Dose 2 (Drug)
结局指标
主要结局
AUCt
时间窗: Based on samples collected 0-96 hours
Cmax
时间窗: 0-96 hours
AUCinf
时间窗: Based on samples collected 0-96 hours
次要结局
- Number patients with abnormal vital sign measurements(Days 1-5)
- Number of patients with abnormal clinical laboratory results(Days 1-5)
- Number of patients with treatment-emergent adverse events(Days 1-14)
- Number of patients with abnormal corrected QTc interval(Days 1-5)
研究者
研究点 (2)
Loading locations...
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