Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
Lead
Genentech, Inc.
Age
18–80
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib
