A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics of Inavolisib

Genentech, Inc.4 个研究点分布在 1 个国家目标入组 32 人开始时间: 2025年8月21日最近更新: 2026年9月18日

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: Genentech, Inc.
入组人数: 32
试验地点: 4
主要终点: Maximum Observed Concentration (Cmax) of Inavolisib

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

This open-label study will evaluate the effect on the pharmacokinetics (PK), safety, and tolerability of a single oral dose of inavolisib in participants with moderate or severe hepatic impairment compared with demographically matched healthy participants with normal hepatic function.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•All participants:
•Body Mass Index 18.0 to 40.0 kilogram per meter square (kg/m^2), inclusive, and body weight >=45 kg.
•Negative hepatitis B surface antigen (HBsAg) test
•Positive hepatitis B surface antibody (HBsAb) test or negative HBsAb
•Negative HIV (Human Immunodeficiency Virus) test
•Females will not be pregnant or breastfeeding and must be either postmenopausal or surgically sterile
•Males will agree to use contraception and will refrain from sperm donation
•Healthy participants (Cohort 1):
•Negative hepatitis C virus (HCV) antibody test or positive HCV antibody test followed by a negative HCV RNA test
•Normal hepatic function and no history of clinically significant hepatic dysfunction
•Participants with Hepatic Impairment (Cohorts 2 and 3):
•Considered to have moderate (Child-Pugh score of 7 to 9) or severe (Child-Pugh score of 10 to 15) hepatic impairment
•Chronic, stable hepatic insufficiency with features of cirrhosis
•Negative hepatitis C viral load

排除标准

•All participants:
•History of Type 1 diabetes or Type 2 Diabetes that is insulin-dependent or requires ongoing systemic treatment with two or more agents
•Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder
•Significant illness, surgery, or hospitalization within 2 weeks prior to dosing.
•History of gastro-intestinal surgery
•Malabsorption syndrome or any other condition that would interfere with enteral absorption.
•History of active or latent Mycobacterium tuberculosis (TB), regardless of treatment history, or positive QuantiFERON® TB Gold test
•History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
•Use of drugs of abuse (including opioids)
•Healthy participants (Cohort 1):
•- History of alcoholism or drug addiction
•Participants with Hepatic Impairment (Cohorts 2 and 3):
•Hepatic impairment due to hepatocellular carcinoma or bile duct cancer
•Surgical or artificial portosystemic shunt (e.g., transjugular intrahepatic portosystemic shunt)
•Evidence of hepatorenal syndrome
•Ascites requiring paracentesis
•Any evidence of progressive liver disease in the last 1 month
•Receipt of a liver transplant
•Hepatic encephalopathy Grade 2 or above

研究组 & 干预措施

Cohort 2

Experimental

Participants with moderate hepatic function will receive a single oral dose of inavolisib on Day 1

干预措施: Inavolisib (Drug)

Cohort 3

Experimental

Participants with severe hepatic function will receive a single oral dose of inavolisib on Day 1

干预措施: Inavolisib (Drug)

Cohort 1

Experimental

Participants with normal hepatic function will receive a single oral dose of inavolisib on Day 1

干预措施: Inavolisib (Drug)