Overview
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.
Eligibility
Inclusion Criteria:
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
Exclusion Criteria:
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