A PHASE 1, NON-RANDOMIZED, OPEN LABEL, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF 06651600 IN SUBJECTS WITH HEPATIC IMPAIRMENT AND IN HEALTHY SUBJECTS WITH NORMAL HEPATIC FUNCTION
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Area Under the Plasma Concentration-time Profile From Time 0 to 24 Hours (AUC24) for PF-06651600
研究概览
简要总结
The purpose of this study is to characterize the effect of hepatic impairment on the pharmacokinetic(s) (PK) of PF-06651600 following administration of multiple once daily doses of PF-06651600. The safety and tolerability of PF-06651600 will also be evaluated in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations and other study procedures
- •Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lb)
- •Additional Inclusion Criteria for Participants with Normal Hepatic Function:
- •Healthy male or female participants
- •No known or suspected hepatic disease
- •Additional Inclusion Criteria for Participants with Impaired Hepatic Function:
- •Stable hepatic impairment, defined as no clinically significant change in disease status within the last 30 days prior to the Screening visit
- •No other ongoing clinically significant abnormalities based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests except for the abnormal findings that are related to the participant's hepatic impairment.
- •Satisfy the criteria for Class A or Class B of the Child-Pugh classification (mild: Child-Pugh Scores 5-6 points, and moderate: Child Pugh Scores 7-9 points), within 28 days of investigational product administration.
排除标准
- •Has active acute or chronic infection requiring treatment or history of systemic infection requiring hospitalization, incl. herpes zoster, herpes simplex, tuberculosis
- •Infection with hepatitis B, hepatitis C or HIV
- •Any condition affecting drug absorption, distribution, metabolism and excretion (eg, status post porta-caval shunt surgery, prior bariatric surgery, gastrectomy, ileal resection)
- •Has malignancy, lymphoproliferative disorder, surgery or other condition not allowed per protocol
- •Additional Exclusion Criteria for Participants with Normal Hepatic Function:
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, gynecologic or allergic disease
- •Additional Exclusion Criteria for Participants with Impaired Hepatic Function:
- •Has encephalopathy, severe ascites and/or pleural effusion, Child-Pugh score >9 or medical conditions (like hepatorenal syndrome, gastrointestinal hemorrhage, etc.) excluded per protocol
研究组 & 干预措施
PF-06651600 Moderate Hepatic Impairment
This arm includes participants with moderate hepatic impairment who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10.
干预措施: PF-06651600 30 mg (Drug)
PF-06651600 Healthy participants
This arm includes healthy adult participants who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10.
干预措施: PF-06651600 30 mg (Drug)
PF-06651600 Mild Hepatic Impairment
This arm is in Part 2 which will be conducted if the decision criterion to proceed to Part 2 is met.
The arm includes participants with mild hepatic impairment who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10.
干预措施: PF-06651600 30 mg (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Profile From Time 0 to 24 Hours (AUC24) for PF-06651600
时间窗: Hour 0 (pre-dose) on Days 7, 8 and 9, and hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours post-dose on Day 10
AUC24 of PF-06651600 pre and post dose.
Maximum Plasma Concentration (Cmax) for PF-06651600
时间窗: Hour 0 (pre-dose) on Days 7, 8 and 9, and hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours post-dose on Day 10
Cmax is maximum observed plasma concentration.
次要结局
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related)(Baseline (Day 0) up to 28 days after last dose of study medication (Day 39))
- Number of Adverse Events Leading to Discontinuation(Baseline (Day 0) up to 28 days after last dose of study medication (Day 39))
- Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)(Baseline (Day 0) up to 28 days after last dose of study medication (Day 39))
- Number of Participants With Out of Range Vital Signs(Baseline (Day 0) up to 28 days after last dose of study medication (Day 39))