A PHASE 1, OPEN-LABEL, SINGLE-DOSE, NON-RANDOMIZED PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS, SAFETY, AND TOLERABILITY OF OSIVELOTOR (PF-07940367) IN ADULT PARTICIPANTS WITH MILD AND MODERATE HEPATIC IMPAIRMENT
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 8
- 试验地点
- 3
- 主要终点
- Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (AUCinf) of osivelotor
研究概览
简要总结
The purpose of this study is to understand how Osivelotor is processed in people with loss of liver function.
This study is seeking participants that are:
- stable loss of liver function with mild or moderate severity
- none of underlying conditions possibly affecting the study medicine being absorbed by the body
All participants will receive one amount of Osivelotor by mouth before breakfast on the first day at the study clinic. A number of blood samples will be collected to understand how Osivelotor is changed and removed from the body. Participants will also have to undergo physical examination and other tests. This will help to understand if Osivelotor is safe.
Participants will take part in the study for a maximum of 112 days. During this time, participants will have to stay onsite for 5 days. There will be 5 study visits at the study clinic.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) of 16 to 40 kg/m2, inclusive; and a total body weight greater than 50 kg (greater than 110 lb)
- •Stable hepatic impairment that meets the criteria for Class A or B of the Child Pugh classification with no clinically significant change in disease status within the 28 days prior to the screening visit
- •Stable concomitant medications for the management of individual participants' medical history
排除标准
- •Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection, prior status portacaval shunt surgery);
- •Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy;
- •A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, physical examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or MRI;
- •Presence of clinically active Stage 3 or 4 hepatic encephalopathy. Clinically active Stage 2 encephalopathy is allowed if, in the opinion of the investigator, the participant is able to provide informed consent.
研究组 & 干预措施
Group 1
Participants with moderate hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions.
干预措施: Osivelotor (Drug)
Group 2
Participants with mild hepatic impairment will receive a single dose of osivelotor, administered orally under fasted conditions.
干预措施: Osivelotor (Drug)
结局指标
主要结局
Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (AUCinf) of osivelotor
时间窗: 0 hours (pre-dose) to 84 days post-osivelotor dose
Area under the whole blood and plasma concentration versus time curve (AUC) from time zero (pre-dose) to the last quantifiable concentration (AUClast) of osivelotor
时间窗: 0 hours (pre-dose) to 84 days post-osivelotor dose
Maximum observed whole blood and plasma concentration (Cmax) of osivelotor
时间窗: 0 hours (pre-dose) to 84 days post-osivelotor dose
次要结局
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings(From baseline up to 84 days after osivelotor dose)
- Number of Participants With Clinically Significant Laboratory Abnormalities(From baseline up to 84 days after osivelotor dose)
- Number of Participants With Treatment-Emergent Adverse Events (AEs)(From baseline up to 56 days after osivelotor dose)
- Number of Participants With Clinically Significant With Clinically Significant Vital Signs(From baseline up to 84 days after osivelotor dose)