A PHASE 1, RANDOMIZED, OPEN-LABEL, 2-PERIOD, 2-SEQUENCE, SINGLE-DOSE, CROSSOVER STUDY IN HEALTHY PARTICIPANTS TO EVALUATE THE EFFECT OF FOOD ON THE RELATIVE BIOAVAILABILITY OF PRIFETRASTAT
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Pfizer
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time zero to time of last measurable concentration (AUClast) for Prifetrastat
研究概览
简要总结
The purpose of the study is to assess the effect of food (high-fat, high-calorie meal) on the total and peak drug exposure of the planned to be marketed tablet formulation of prifetrastat.
This study is seeking participants who are:
- Healthy males and females of nonchildbearing potential ≥18 years of age at screening
The participants will receive study medicine prifetrastat as a single tablet by mouth at study clinic under fed or fasted condition. After at least 14 days, they will receive another single tablet of prifetrastat by mouth under fasted or fed condition. The sequence of conditions (fed or fasted first) will be randomized.
The results of this study will enable data-driven guidance regarding food intake for participants enrolled in clinical studies of prifetrastat as well as patients receiving prifetrastat post-marketing. Participants will remain in clinic for about 21 days and 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 nonchildbearing 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.
- •Body mass Index (BMI) of 18-32 kg/m2; and a total body weight >50 kg (110 lb).
排除标准
- •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
- •Any prior use of epigenetic modifying agents.
- •Current use or anticipated need for food or drugs that are known moderate or strong inducers or inhibitors of CYP2C9 or CYP3A4, including their administration within 14 days plus 5 half-lives of the inducers or 14 days or 5 half lives (whichever is longer) for the inhibitors of CYP2C9 or CYP3A4, prior to first dose of study intervention, during the treatment period, and within 6 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.
结局指标
主要结局
Area under the concentration-time curve from time zero to time of last measurable concentration (AUClast) for Prifetrastat
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose
Maximum observed plasma concentration (Cmax) for Prifetrastat
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose
Area under the concentration-time curve from time zero to extrapolated infinite time (AUCinf) for Prifetrastat
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours post-dose
次要结局
- Number of participants with vital signs values meeting categorical summarization criteria(Up to 28 to 35 days post last study intervention dose)
- Number of participants with clinically significant physical examination abnormalities(Up to 28 to 35 days post last study intervention dose)
- Number of participants with treatment-emergent adverse events(Up to 28 to 35 days post last study intervention dose)
- Number of participants with laboratory test abnormalities(Up to 28 to 35 days post last study intervention dose)
- Number of participants with treatment emergent clinically significant abnormal electrocardiogram (ECG) measurements(Up to 28 to 35 days post last study intervention dose)