A Phase 1, Open-Label, Randomized, Single Dose Study To Estimate The Relative Bioavailability And Food Effect Of PF-06291826 (Tafamidis) Following Administration Of New Soft Gelatin Capsule Oral Formulations In Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Area under the concentration-time Curve (AUC)
研究概览
简要总结
This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 6 days. After another 14 days, the last formulation will be tested in the same way. In part 2 of the study, depending on the results of part 1, either none, one or 2 of the formulations tested in part 1 will be tested comparing the same formulation when given either with or without food. Additionally, depending on the results of part 1 of the study, different doses of the formulations may be compared.
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
- •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 7 days of the study.
- •Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.
研究组 & 干预措施
4 soft gel capsules of 20 mg tafamidis meglumine
干预措施: tafamidis (Drug)
48.8 mg tafamidis soft gel capsule formulation 1
干预措施: tafamidis (Drug)
48.8 mg tafamidis soft get capsule formulation 2
干预措施: tafamidis (Drug)
61 mg tafamidis soft gel capsule formulation 1
干预措施: tafamidis (Drug)
61 mg tafamidis soft gel capsule formulation 2
干预措施: tafamidis (Drug)
结局指标
主要结局
Area under the concentration-time Curve (AUC)
时间窗: 120 hours
Maximum Observed Plasma Concentration (Cmax)
时间窗: 120 hours
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(120 hours)
- Area Under the Curve from Time zero to infinity(120 hours)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(120 hours)
- Plasma Decay Half-Life (t1/2)(120 hours)