A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib
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
- Hepatic Impairment
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort 1 |
Participants with normal hepatic function will receive a single oral dose of inavolisib on Day 1 |
|
|
Experimental Cohort 2 |
Participants with moderate hepatic function will receive a single oral dose of inavolisib on Day 1 |
|
|
Experimental Cohort 3 |
Participants with severe hepatic function will receive a single oral dose of inavolisib on Day 1 |
|
Recruiting Locations
Lake Forest 5364514, California 5332921 92630
Orlando 4167147, Florida 4155751 32809
San Antonio 4726206, Texas 4736286 78215
San Antonio 4726206, Texas 4736286 78229
More Details
- Status
- Recruiting
- Sponsor
- Genentech, Inc.
Study Contact
Reference Study ID Number: GP45942 https://forpatients.roche.com888-662-6728 (U.S. and Canada)
global-roche-genentech-trials@gene.com