A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO ASSESS PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-07817883 IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITHOUT HEPATIC IMPAIRMENT
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 16
- 试验地点
- 6
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of PF-07817883
研究概览
简要总结
The purpose of the study is to learn about the safety of PF-07817883 and how PF-07817883 is processed in the body of adult participants. These participants will have different degrees of loss of liver function. Participants with mild, moderate, severe or no loss of liver function will be enrolled in 4 groups.
This study is seeking participants who:
- are male or female of 18- 75 years of age
- either have different amounts of damage to liver function or for one of the groups, no damage
- willing to follow the requirements of the study including stay at clinic for 6 nights and 7 days
About, 6-8 participants will be enrolled in group 1 (participants without loss of liver function) and group 3 (participants with moderate loss of liver function). In group 4 (participants with severe loss of function), around 4 to 8 participants will be enrolled. Participants in group 2 (mild loss of function) will only be enrolled after review of the data from groups 3 and 4.
If participants consent to participate in the study, it may take up to 4 weeks to complete all the tests to confirm if they are eligible to participate in the study. If they seem to be eligible for the study, participants will be admitted to a clinic research unit (CRU) at least 12 hours before dosing. On Day 1, participants will receive a single dose of study medicine (Day 1). A series of blood samples will be collected before and after dosing. Participants will be discharged from the CRU on Day 6. A follow-up phone call (on CRU visit, if needed), will occur 28-35 days after dosing.
The whole study will last for a minimum of 5 weeks and a maximum of 10 weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(HI Cohorts Only): Stable HI that meets criteria for Class A or B of the Child-Pugh classification;
- •(all Cohorts): BMI of 17.5 to 38.0 kg/m2
排除标准
- •Any condition possibly affecting drug absorption Additional Exclusion Criteria for HI Cohorts Only
- •Limited predicted life expectancy
- •Hepatic dysfunction secondary to acute ongoing hepatocellular process.
- •Signs of clinically active Grade 2, 3 or 4 hepatic encephalopathy.
- •Severe ascites and/or pleural effusion
- •History of kidney, liver, or heart transplantation.
- •Persistent severe, uncontrolled hypertension.
研究组 & 干预措施
Cohort 1
No hepatic impairment
干预措施: PF-07817883 (Drug)
Cohort 2
Mild hepatic impairment
干预措施: PF-07817883 (Drug)
Cohort 3
Moderate hepatic impairment
干预措施: PF-07817883 (Drug)
Cohort 4
Severe hepatic impairment
干预措施: PF-07817883 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of PF-07817883
时间窗: Day 1 to Day 6
Plasma PF-07817883 PK parameters
Area Under the Plasma Concentration-time Profile from Time Zero to Extrapolated Infinite Time (AUCinf)
时间窗: Day 1 to Day 6
Plasma PF-07817883 PK parameter
Area Under the Plasma Concentration-time Profile from Time Zero to the Time of the Last Quantifiable Concentration (AUClast)
时间窗: Day 1 to Day 6
(Optional) Plasma PF-07817883 parameter
次要结局
- Number of Participants with Non-Serious Adverse Events(Screening to Day 35)
- Number of Participants with Treatment Emergent Adverse Events(Day 1 to Day 35)
- Number of Participants with Clinically Significant ECG Abnormalities(Day 1 to Day 6)
- Number of Participants with Clinically Significant Abnormal Vital Signs(Day 1 to Day 6)
- Number of Participants with Clinically Significant Abnormal Laboratory Values(Baseline to Day 6)
- Number of Participants with Serious Adverse Events(Screening to Day 35)