A Double Blind (3rd Party Open) Randomized, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics of Repeat Doses PF-06305591 Combined With a Cross-over Relative Bioavailability and Food Effect Evaluation After Single Dose of PF-06305591 in Healthy Young Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
Safety, tolerability and PK of repeated doses of PF-06305591 will be evaluated in young healthy volunteers toghether with food effect on relative bioavailability of solid formulation after single dose.
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
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects of non childbearing potential, between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Any condition possibly affecting drug absorption (eg, gastrectomy).
研究组 & 干预措施
Multiple Dose: Cohort 3
干预措施: PF-06305591 (Drug)
Multiple Dose: Cohort 3
干预措施: Placebo (Drug)
Multiple Dose: Cohort 2
干预措施: PF-06305591 (Drug)
Multiple Dose: Cohort 2
干预措施: Placebo (Drug)
Multiple Dose: Cohort 1
干预措施: PF-06305591 (Drug)
Multiple Dose: Cohort 1
干预措施: Placebo (Drug)
Multiple Dose: Cohort 4
干预措施: PF-06305591 (Drug)
Relative Bioavilability: Cohort 1
干预措施: PF-06305591 (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: 14 days
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Area under the Concentration-Time Curve (AUC)
时间窗: 14 days
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
时间窗: 14 days
AUC is a measure of the serum concentration of the drug over time interval. It is used to characterize drug absorption.
Maximum Observed Plasma Concentration (Cmax)
时间窗: 14 days
次要结局
未报告次要终点