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NCT07144111
A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib
Conditions: Hepatic Impairment
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 32
Sponsor: Genentech, Inc.
Location: Orange County Research Center Lake Forest California
Summary
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 Criteria
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
Source: ClinicalTrials.gov (NCT07144111). StuddyBuddy aggregates publicly available trial information.