Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cohort 1
Participants with normal hepatic function will receive a single oral dose of inavolisib on Day 1
  • Drug: Inavolisib
    Participants will receive a single oral dose of inavolisib
Experimental
Cohort 2
Participants with moderate hepatic function will receive a single oral dose of inavolisib on Day 1
  • Drug: Inavolisib
    Participants will receive a single oral dose of inavolisib
Experimental
Cohort 3
Participants with severe hepatic function will receive a single oral dose of inavolisib on Day 1
  • Drug: Inavolisib
    Participants will receive a single oral dose of inavolisib

Recruiting Locations

Orange County Research Center
Lake Forest 5364514, California 5332921 92630

Orlando Clinical Research Center
Orlando 4167147, Florida 4155751 32809

The Texas Liver Institute, Inc.
San Antonio 4726206, Texas 4736286 78215

Pinnacle Clinical Research - San Antonio
San Antonio 4726206, Texas 4736286 78229

More Details

Status
Recruiting
Sponsor
Genentech, Inc.

Study Contact

Reference Study ID Number: GP45942 https://forpatients.roche.com
888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.