A PHASE 1, OPEN-LABEL, RANDOMIZED, THREE-PERIOD, THREE-SEQUENCE, SINGLE-DOSE, CROSSOVER STUDY IN FASTED HEALTHY SUBJECTS, TO ASSESS THE SAFETY, PHARMACOKINETICS AND ORAL BIOAVAILABILITY OF TAFAMIDIS FREE ACID WET-MILLED SUSPENSION DOSES, RELATIVE TO 4 X 20 MG COMMERCIAL TAFAMIDIS MEGLUMINE CAPSULES
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
- 1. Area under the plasma concentration-time profile from time 0 extrapolated to infinite time (AUCinf)
研究概览
简要总结
2 different formulations and 4 different single doses of tafamidis will be compared. All subjects will receive both formulations and 3 different doses. Subjects will be fasted before taking the drug. After swallowing single dose of tafamidis, tafamidis blood concentrations will be measured periodically for 8 days. After another 16 days, all subjects will repeat the procedure twice, each time with the other formulation/dose.
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
- 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 males or females of non-child bearing potential.
- •Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
- •Use of prescription or nonprescription drugs supplements within 7 days prior to the study.
- •Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
研究组 & 干预措施
Treatment A
4 × 20 mg commercial tafamidis meglumine administered as soft gelatin capsules under fasted conditions
干预措施: Tafamidis (Drug)
Treatment B
10 mgA tafamidis free acid administered as a wet-milled suspension under fasted conditions
干预措施: Tafamidis (Drug)
Treatment C
a dose of tafamidis free acid projected to be an equivalent of 4 × 20 mg commercial tafamidis meglumine administered as a wet-milled suspension under fasted conditions
干预措施: Tafamidis (Drug)
Treatment D
a dose of tafamidis free acid projected to be an equivalent of 5 × 20 mg commercial tafamidis meglumine administered as a wet-milled suspension under fasted conditions
干预措施: Tafamidis (Drug)
结局指标
主要结局
1. Area under the plasma concentration-time profile from time 0 extrapolated to infinite time (AUCinf)
时间窗: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs
2. Maximum Observed Plasma Concentration (Cmax)
时间窗: 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs
次要结局
- 2. Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)(0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs)
- 1. Area under the plasma concentration-time profile from time 0 to 24 hours post-dose (AUC24)(0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs)
- 3. Time to Reach Maximum Observed Plasma Concentration (Tmax)(0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs)