A Phase 1, Open-Label Study to Characterize the Pharmacokinetics and Safety of a Single Oral Dose of GBT440 in Subjects With Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- To assess the Tmax of GBT440 in patients with mild, moderate, or severe hepatic impairment
研究概览
简要总结
A Phase 1, multiple center, nonrandomized, open-label, parallel group study of a single oral dose of GBT440 administered in subjects with mild (Child-Pugh A), moderate (Child-Pugh B), or severe (Child-Pugh C) hepatic impairment disease and healthy subjects with normal hepatic function.
详细描述
Approximately 24 to 28 subjects will be enrolled. Safety and PK assessments will be performed at selected time points throughout the 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
- Other
- 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
- •All subjects:
- •Males or females, 18 to 75 years old
- •Willing and able to give written informed consent
- •Patients with hepatic impairment:
- •Mild hepatic impairment (Child-Pugh A [5-6 points])
- •Moderate hepatic impairment (Child-Pugh B [7-9 points])
- •Severe hepatic impairment (Child-Pugh C [10-15 points])
- •Healthy subjects:
- •Match in age, gender and body mass index with hepatic impaired subjects
- •Healthy and without clinically significant abnormalities in vital signs, ECGs, physical exam, clinical laboratory evaluations, medical and surgical history
排除标准
- •All subjects:
- •Participation in another clinical trial of an investigational drug (or medical device) within 30 days of the last dose of investigational drug or 5 half-lives whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device)
- •Any signs or symptoms of acute illness at screening or Day -1
- •History or presence of clinically significant allergic, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease
- •Patients with hepatic impairment:
- •History of liver transplantation, hepatic mass suggestive of hepatocellular carcinoma or acute liver disease
- •Screening serum ALT or AST >5 times the upper limit of normal
研究组 & 干预措施
GBT440 Dose 1:Mild hepatic impairment
Child Pugh A
干预措施: GBT440 (Drug)
GBT440 Dose 1:Moderate hep. impairment
Child Pugh B
干预措施: GBT440 (Drug)
GBT440 Dose 1:Severe hepatic impairment
Child Pugh C
干预措施: GBT440 (Drug)
GBT440 Dose 1:Normal hepatic function
Healthy subjects
干预措施: GBT440 (Drug)
结局指标
主要结局
To assess the Tmax of GBT440 in patients with mild, moderate, or severe hepatic impairment
时间窗: 28 days max
Time at which maximum concentration was observed
To assess the Cmax of GBT440 in patients with mild, moderate, or severe hepatic impairment
时间窗: 28 days max
Maximum observed plasma concentration
To assess the T1/2 of GBT440 in patients with mild, moderate, or severe hepatic impairment
时间窗: 28 days max
Terminal elimination half-life
To assess the AUC of GBT440 in patients with mild, moderate, or severe hepatic impairment
时间窗: 28 days max
Area under the concentration-time curve
次要结局
- Physical examination findings(28 days max)
- Clinical laboratory tests(28 days max)
- Adverse events(28 days max)
- Vital signs(28 days max)
- Electrocardiograms(28 days max)