NCT01369836已完成1 期
An Investigator And Subject-Blind Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06291826 (Tafamidis) After Single Oral Administration To Japanese And Western 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
- 发起方
- Pfizer
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Plasma concentration of tafamidis over time (AUClast).
研究概览
简要总结
The purpose of this study is the following:
- To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered tafamidis in Japanese and Western healthy volunteers at single dose.
- To compare Japanese and Western PK profiles.
- Determine the PD stabilization effect of tafamidis on human transthyretin (TTR) in a validated ex vivo assay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Healthy male or females.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.
排除标准
- •Pregnant or nursing females.
- •Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
研究组 & 干预措施
20 mg soft gelatin capsule
Experimental
干预措施: Tafamidis meglumin (Drug)
40 mg (20 mg*2) soft gelatin capsule
Experimental
干预措施: Tafamidis meglumin (Drug)
Placebo
Active Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Plasma concentration of tafamidis over time (AUClast).
时间窗: 2 months
Plasma concentration of tafamidis over time (Cmax).
时间窗: 2 months
Plasma concentration of tafamidis over time (Tmax).
时间窗: 2 months
If data permit, AUCinf and t1/2 will be determined.
时间窗: 2 months
次要结局
- The percent stabilization of TTR tetramer will be defined at Cmax in each subject and compared between Japanese volunteers and Western volunteers.(2 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Phase I Study of HS-10386 in Participants With Advanced Solid TumorsAdvanced Solid TumorNCT05911464Jiangsu Hansoh Pharmaceutical Co., Ltd.248
终止
1 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid TumorsAdvanced Solid TumorsMSI-H/dMMR TumorsCutaneous Squamous Cell CarcinomaUrothelial Carcinoma, HCCEsophageal Squamous Cell CarcinomaSmall-cell Lung CancerCervical CancerMerkel Cell CarcinomaMesotheliomaPD-L1 Amplified Tumor (9p24.1)Cyclin-dependent Kinase 12 Mutated TumorsBasal Cell Carcinoma (Unresectable or Metastatic)Sarcomatoid Renal Cell CarcinomaClear Cell Ovarian or Endometrial CarcinomaAnal CarcinomaSquamous Cell Penile CarcinomaNasopharyngeal CarcinomaDNA Polymerase Epsilon Mutated Tumors (P286R and V411L)NCT04272034Incyte Corporation105
已完成
1 期
Safety, Tolerability and Pharmacokinetic Study of MRG-201 in Healthy VolunteersHealthy VolunteersNCT02603224miRagen Therapeutics, Inc.54
招募中
1 期
Assessment of Safety, Tolerability and Pharmacokinetics With BAT8010 for Injection in Advanced Malignant Solid Tumors PatientsAdvanced or Metastatic Solid TumorsNCT05848466Bio-Thera Solutions109
已完成
1 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid TumorsAdvanced Solid TumorMSI-H/dMMR TumorsCutaneous Squamous Cell CarcinomaUrothelial CarcinomaEsophageal Squamous Cell CarcinomaCervical CancerHepatoCellular CarcinomaSmall-cell Lung CancerMesotheliomaPD-L1 Amplified Tumor (9p24.1)Merkel Cell CarcinomaNasopharyngeal CarcinomaNCT04242199Incyte Corporation182