A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE STUDY TO COMPARE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-04965842 IN ADULT SUBJECTS WITH MILD AND MODERATE HEPATIC IMPAIRMENT RELATIVE TO 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
- 24
- 试验地点
- 2
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) for PF-04965842
研究概览
简要总结
This is a Phase 1 non randomized, open label, single dose, parallel cohort study to investigate the effect of hepatic impairment on the PK, safety and tolerability of PF 04965842.
详细描述
A minimum of 24 subjects with normal, mild or moderate hepatic function will be enrolled into the study, with approximately 8 subjects in each cohort. The Child Pugh classification score will be utilized to assess entry criteria and to assign subjects into the appropriate hepatic impairment group. For individual subjects, the total maximum duration of study participation from the Screening visit to the end of clinical research unit (CRU) stay is approximately 31 days and approximately 63 days from the Screening visit to the Follow up contact.
研究设计
- 研究类型
- Interventional
- 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
- •Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 pounds).
- •Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Additional Inclusion Criteria for subjects with hepatic impairment:
- •Satisfy the criteria for Class A or Class B of the Child Pugh classification (mild: Child Pugh Scores 5 to 6 points, and moderate: Child Pugh Scores 7 to 9 points), within 14 days of investigational product administration.
- •A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to any acute ongoing hepatocellular process) documented by medical history, physical examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or magnetic resonance imaging (MRI).
排除标准
- •Subjects with clinically significant infections within the past 3 months (for example, those requiring hospitalization, or as judged by the Investigator), evidence of any infection (including influenza) within the past 7 days, history of disseminated herpes simplex infection or recurrent (>1 episode) or disseminated herpes zoster.
- •Subjects with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
- •Additional exclusion criteria for subjects with hepatic impairment:
- •Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy (defined as less than 1 year).
- •Subjects who have previously had a transplanted kidney, liver, or heart.
- •At Screening, persistent severe, uncontrolled hypertension.
研究组 & 干预措施
PF-04965842
PF 04965842 is an orally bioavailable small molecule that selectively inhibits JAK1.
干预措施: PF-04965842 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) for PF-04965842
时间窗: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72 hours post-dose in each cohort
Cmax is maximum plasma concentration. It was observed directly from data.
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) for PF-04965842
时间窗: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 14, 24, 36, 48, 72 hours post-dose in each cohort
AUCinf is area under the concentration-time curve (AUC) from time 0 (pre-dose) extrapolated to infinite time.
次要结局
- Number of Participants With Treatment-Emergent Adverse Events (AEs) for PF-04965842(From screening (within 28 days prior to Day 1) till up to 36 days post-dose, the total maximum duration was approximately 63 days for individual participants.)
- Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance for PF-04965842(Screening (within 28 days prior to Day 1), Day -1, 2, 72 hours post-dose.)
- Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)(Screening (within 28 days prior to Day 1), Day -1, 2, 24, 72 hours post-dose.)
- Number of Participants With Vital Sign Findings of Potential Clinical Importance for PF-04965842(Screening (within 28 days prior to Day 1), 0 (pre-dose), and 72 hours post-dose.)