A PHASE 1, RANDOMIZED, OPEN-LABEL, 2 ARM, 2-PERIOD, CROSS-OVER, SINGLE-DOSE STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE RELATIVE BIOAVAILABILITY OF TWO PF-07248144 CLINICAL TRIAL FORMULATIONS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07248144 Form 1 uncoated tablet
研究概览
简要总结
Study has two arms. Arm 1 has two cohorts in which each cohort, under the fasted state, will either be given a single oral dose of Form 1 in Period 1 followed by a single oral dose of Form 5 in Period 2 or a single oral dose of Form 5 in Period 1 followed by a single oral dose of Form 1 in Period 2. A single oral dose of Form 1 will be administered in Arm 2 Period 1 under the fasted state. The results from Arm 1 will inform whether a different dose of Form 5 will be administered under the fasted state or if Form 5 will be administered under the fed state in Arm 2 Period 2.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PF-07248144 Form 1 (uncoated) Arm
Period 1: Participants received Form 1 in a single dose of tablet fasted Period 2: Participants received Form 5 in a single dose of tablet fasted
干预措施: PF-07248144 (Drug)
PF-07248144 Form 5 (film-coated) Arm
Period 1: Participants received Form 5 in a single dose of tablet fasted Period 2: Participants received Form 1 in a single dose of tablet fasted
干预措施: PF-07248144 (Drug)
PF-07248144 Form 5 (film-coated) Adaptive Arm
Period 1: Fasted participants received a single dose of tablet of Form 1 orally Period 2: Participants received a single dose of tablet orally of Form 5 in a fed state
干预措施: PF-07248144 (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-07248144 Form 1 uncoated tablet
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose
AUCinf for PF-07248144 Form 5 film-coated tablet
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for PF-07248144 Form 1 uncoated tablet
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose
Cmax for PF-07248144 Form 5 film-coated tablet
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, and 168 hours post-dose
次要结局
- Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria(From Baseline up to Day 35)
- Number of Participants With Clinically Significant Physical Examination Abnormalities(From Baseline up to Day 35)
- Number of Participants With Treatment Emergent Treatment Related AEs and SAEs(From Baseline up to Day 35)
- Number of Participants With Laboratory Test Abnormalities(From Baseline up to Day 35)