A Phase 1, Open-label, Single-dose, Parallel Cohort Study to Assess the Pharmacokinetics and Safety of Fosmanogepix (PF 07842805) in Adult Participants With Varying Degrees of Hepatic Impairment

Basilea Pharmaceutica2 个研究点分布在 1 个国家目标入组 28 人开始时间: 2022年10月31日最近更新: 2025年12月19日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Basilea Pharmaceutica
入组人数: 28
试验地点: 2
主要终点: Maximum Observed Plasma Concentration (Cmax) of manogepix

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary purpose of this open-label study is to characterize the plasma pharmacokinetics (PK) of manogepix (active moiety of fosmanogepix) in participants with varying degrees of hepatic function following administration of a single oral dose of fosmanogepix.

All participants will receive 1 dose of fosmanogepix by mouth before breakfast on the first day at the study clinic. Serial blood samples will be collected to understand how fosmanogepix is changed and eliminated from the body. Participants will also receive physical examination and other tests. This will help to understand if fosmanogepix is safe.

Participants will be involved in this study for 4 to 9 weeks (maximum). There will be 2 to 4 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 75 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 40.0 kg/m2 (42 kg/m2 for participants of Cohort 3), inclusive; and a total body weight greater than 50 kg (greater than 110 lb)
•For participants with hepatic impairment (Cohorts 1-3, and Cohort 5): Stable hepatic impairment that meets the criteria for Class A, B, or C of the Child Pugh classification with no clinically significant change in disease status within the 28 days prior to the screening visit
•For participants with normal hepatic function (Cohort 4): No clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests
•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);
•Ongoing medical history of neurological disorders including abnormal movements or seizures (Note exception: stable history of peripheral neuropathy);
•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;
•Signs of clinically active Grade 2, 3 or 4 hepatic encephalopathy (ie, equal or greater than Grade 2 Portal Systemic Encephalopathy score)

研究组 & 干预措施

Cohort 5: Fosmanogepix Participants with severe hepatic impairment (new dose level)

Experimental

Participants with severe hepatic impairment will receive a single dose of fosmanogepix, administered orally as 2 fosmanogepix tablets under fasted conditions.

干预措施: Fosmanogepix (Drug)

Cohort 1: Fosmanogepix participants with mild hepatic impairment

Experimental

Participants with mild hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.

干预措施: Fosmanogepix (Drug)

Cohort 2: Fosmanogepix Participants with moderate hepatic impairment

Experimental

Participants with moderate hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.

干预措施: Fosmanogepix (Drug)

Cohort 3: Fosmanogepix Participants with severe hepatic impairment

Experimental

Participants with severe hepatic impairment will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.

干预措施: Fosmanogepix (Drug)

Cohort 4: Fosmanogepix Participants with normal hepatic function (control group)

Experimental

Participants with normal hepatic function will receive a single dose of fosmanogepix, administered orally as 1 fosmanogepix tablet under fasted conditions.

干预措施: Fosmanogepix (Drug)