NCT01655511已完成1 期
A Phase 1, Randomized, Double-Blind, Crossover, Ascending Dose-Tolerance Study To Assess The Safety And Pharmacokinetics Of Tafamidis Doses Greater Than 120 Mg As Oral Solution In Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of orally administered tafamidis in healthy volunteers at escalating doses >120 mg. Safety assessments will include spontaneous reporting of adverse events, concomitant medications, physical examination,
研究概览
简要总结
This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, males or females, 21 to 55 years old.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Condition affecting drug absorption. Blood pressure or ECG abnormalities. Recent treatment with an investigational, prescription, or non-prescription drug
研究组 & 干预措施
Period 1
Experimental
240 mg tafamidis arm
干预措施: Tafamidis (Drug)
Period 2
Experimental
480 mg arm
干预措施: Tafamidis (Drug)
Period 3
Experimental
TBD dose
干预措施: Tafamidis (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of orally administered tafamidis in healthy volunteers at escalating doses >120 mg. Safety assessments will include spontaneous reporting of adverse events, concomitant medications, physical examination,
时间窗: Day 0 and Day 6
vital signs, ECGs, and clinical laboratory tests.
时间窗: Day 0 and Day 6
次要结局
- Cmax - Maximum Observed Plasma Concentration (Cmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs)
- tmax - Time to Reach Maximum Observed Plasma Concentration (Tmax)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs)
- AUC0-24 - AreArea under the Concentration-Time Curve (AUC)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs)
- AUClast - Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)](0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs)
- AUCinf - Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)](0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs)
- t½ - Plasma Decay Half-Life (t1/2)(0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, and 120 hrs)
- Transthyretin blood concentration in mg/dL(Days 0,1,2,3,4,5,6)
- Transthyretin stabilization (%)(Days 0,1,2,3,4,5,6)
研究者
研究点 (1)
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