A PHASE 1, RANDOMIZED, OPEN-LABEL, 2-PERIOD, 4-SEQUENCE SINGLE-DOSE CROSSOVER STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE RELATIVE BIOAVAILABILITY OF PRIFETRISTAT DRUG PRODUCT DIFFERING IN PARTICLE SIZE DISTRIBUTION
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Reference treatment of prifetrastat (AUClast If data does not permit AUCinf)
研究概览
简要总结
The purpose of this study is to understand the relative amount of drug that enters bloodstream from prifetrastat product lots differing in active ingredient particle size distribution.
The study is seeking participants who are:
Healthy males and females of non-childbearing potential >=18 years of age at screening
Participants in the study will receive a single dose of prifetrastat by mouth. After at least 14 days, they will receive another dose of prifetrastat by mouth. Each dose received by the patient will be in tablet form. The sequence in which tablets are given will be random.
The study will help understand how the difference in particle size distributions of the tablets may, or may not, affect how the drug is absorbed, processed, and eliminated by the body.
Participants will remain in the study clinic for 21 days. However, they may be permitted to leave between periods, and will have one follow-up contact.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females of non-childbearing potential and males >=18 years of age at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
- •BMI of 18-32 kilogram per meter square(Kg/m^2); and a total body weight >50 kg (110 lb).
- •Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention
- •Prior use of epigenetic modifying agents. Participants will only be permitted to enroll in a single arm of this study (cannot participate in Arm 1 and Arm 2).
- •Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
- •current use or anticipated need for food or drugs that are known strong inducers or inhibitors of CYP2C9 or CYP3A4, including their administration within 14 days plus 5 half-lives of the strong inducers or inhibitors of CYP2C9 or CYP3A4, whichever is longer, prior to first dose of study intervention, during the treatment period, and within 2 days after the last dose of prifetrastat
- •Proton pump inhibitors must be discontinued at least 14 days prior to the first dose of study medication and throughout treatment period.
排除标准
- 未提供
结局指标
主要结局
Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Reference treatment of prifetrastat (AUClast If data does not permit AUCinf)
时间窗: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
Maximum Observed Plasma Concentration (Cmax) profile of Reference prifetrastat treatment
时间窗: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
Cmax was the maximum observed plasma concentration directly observed from data.
Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Test 1 treatment of prifetrastat (AUClast If data does not permit AUCinf)
时间窗: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
Maximum Observed Plasma Concentration (Cmax) profile of Test 1 prifetrastat treatment
时间窗: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
Cmax was the maximum observed plasma concentration directly observed from data.
Area under the Plasma Concentration-Time profile from time 0 to extrapolated infinite time (AUCinf) of Test 2 treatment of prifetrastat (AUClast If data does not permit AUCinf)
时间窗: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
AUCinf was area under the plasma concentration time-curve from zero (pre-dose) extrapolated out to infinite time (If data permits).
Maximum Observed Plasma Concentration (Cmax) profile of Test 2 prifetrastat treatment
时间窗: Pre-dose, 0, 0.5, 1, 1.5, 2, 3, 4 ,6 , 8, 12, 24, 36, 48, 72, 96, 144 hours post dose in period 1 and period 2
Cmax was the maximum observed plasma concentration directly observed from data.
次要结局
- Number of Participants with Clinically Significant Abnormalities in Laboratory Parameters(Up to Day 35 after the last dose of study intervention in Period 2)
- Number of Participants With Clinically Significant Abnormalities in Vital Signs(Up to Day 35 after the last dose of study intervention in Period 2)
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities(Up to Day 35 after the last dose of study intervention in Period 2)
- Number of Participants With Clinically Significant Physical Examination Abnormalities(Up to Day 35 after the last dose of study intervention in Period 2)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Up to Day 35 after the last dose of study intervention in Period 2)