A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess Safety, Tolerability, And Pharmacokinetics Of Single Escalating Oral Doses Of Pf-06815345, As Well As Characterize The Pharmacokinetics Of Two Formulations And Effect Of Food On Pharmacokinetics Of One Formulation Of Pf-06815345 Administered To Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs)
研究概览
简要总结
The current study is the first clinical trial proposed with PF-06815345. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single oral doses of PF-06815345 to healthy adult subjects.
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
- Triple (Participant, Care Provider, 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 males and female of non-childbearing potential;
- •Age of 18-55, inclusive;
- •Body Mass Index 17.5-34.9 kg/m2, inclusive;
- •Body weight >50 kg;
- •Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.
排除标准
- •Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
研究组 & 干预措施
Part 1_Cohort 1_Active;
Single ascending dose of PF-06815345
干预措施: PF-06815345 (Drug)
Part 1_Cohort 1_Placebo;
Single dose of placebo
干预措施: Placebo (Other)
Part 1_Cohort 2_Active
Single ascending dose of PF-06815345
干预措施: PF-06815345 (Drug)
Part 1_Cohort 2_Placebo
Single dose of placebo
干预措施: Placebo (Other)
Part 2
Single dose of solid dosage formulation (test) versus liquid dosage formulation (reference) of PF-06815345
干预措施: PF-06815345 (Drug)
结局指标
主要结局
Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs)
时间窗: Baseline (Day 0) up to 28 days after last dose of study medication
Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.
次要结局
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06815345(0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for the metabolite (PF-06811701)(0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose)
- Maximum Observed Plasma Concentration (Cmax) for PF-06815345(0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose)
- Apparent Oral Clearance (CL/F) for PF-06815345(0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose)
- Apparent Volume of Distribution (Vz/F) for PF-06815345(0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose)
- Time to Reach Maximum Observed Concentration for PF-06815345(0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose)
- Maximum Observed Plasma Concentration (Cmax) for metabolite (PF-06811701)(0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose)
- Time to Reach Maximum Observed Concentration for metabolite (PF-06811701)(0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose)
- Plasma Decay Half-Life (t1/2) for metabolite (PF-06811701)(0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06815345(0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose)
- Plasma Decay Half-Life (t1/2) for PF-06815345(0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose)
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for metabolite (PF-06811701)(0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose)