Hepatic Impairment
Conditions
Brief 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.
Interventions
DRUGInavolisib
Participants will receive a single oral dose of inavolisib
Sponsors
Genentech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Concentration (Cmax) of Inavolisib | Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose |
| Area Under Curve (AUC) from Hour 0 to the Last Measurable Concentration (AUC [0-t]) of Inavolisib | Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose |
| AUC from Zero to Infinity (AUC [0-inf]) Extrapolated of Inavolisib | Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose |
| Geometric Mean Ratio of Cmax of Inavolisib | Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose |
| Geometric Mean Ratio of AUC (0-t) of Inavolisib | Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose |
| Geometric Mean Ratio of AUC (0-inf) of Inavolisib | Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) | From Baseline up to Follow-up (Day 8) |
Countries
United States
Contacts
CONTACTReference Study ID Number: GP45942 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Genentech, Inc.
Outcome results
None listed