[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604022":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":33,"locations":41,"responsibleParty":81,"collaborators":28,"id":83,"slug":28,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":28,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":28,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":28,"overallStatus":44,"whyStopped":28,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Genentech, Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Participants with normal hepatic function will receive a single oral dose of inavolisib on Day 1",[13],"Drug: Inavolisib",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2","Participants with moderate hepatic function will receive a single oral dose of inavolisib on Day 1",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3","Participants with severe hepatic function will receive a single oral dose of inavolisib on Day 1",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Inavolisib","Participants will receive a single oral dose of inavolisib",[9,15,19],null,[30],{"name":31,"affiliation":5,"role":32},"Clinical Trials","STUDY_DIRECTOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":28,"email":38},"Reference Study ID Number: GP45942 https:\u002F\u002Fforpatients.roche.com","CONTACT","888-662-6728 (U.S. and Canada)","global-roche-genentech-trials@gene.com",{"name":40,"role":36,"phone":28,"phoneExt":28,"email":28},"Fastest response: use the inquiry form. No email attachments. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[42,55,65,75],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":28},"Orange County Research Center","RECRUITING","Lake Forest","California","92630","United States",{"type":50,"coordinates":51},"Point",[52,53],-117.68922,33.64697,{"lat":53,"lon":52},{"facility":56,"status":44,"city":57,"state":58,"zip":59,"country":48,"cosmosGeoPoint":60,"geoPoint":64,"contacts":28},"Orlando Clinical Research Center","Orlando","Florida","32809",{"type":50,"coordinates":61},[62,63],-81.37924,28.53834,{"lat":63,"lon":62},{"facility":66,"status":44,"city":67,"state":68,"zip":69,"country":48,"cosmosGeoPoint":70,"geoPoint":74,"contacts":28},"The Texas Liver Institute, Inc.","San Antonio","Texas","78215",{"type":50,"coordinates":71},[72,73],-98.49363,29.42412,{"lat":73,"lon":72},{"facility":76,"status":44,"city":67,"state":68,"zip":77,"country":48,"cosmosGeoPoint":78,"geoPoint":80,"contacts":28},"Pinnacle Clinical Research - San Antonio","78229",{"type":50,"coordinates":79},[72,73],{"lat":73,"lon":72},{"type":82,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100604022",false,"NCT07144111","A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib","A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics of Inavolisib","Inclusion Criteria:\n\nAll participants:\n\n* Body Mass Index 18.0 to 40.0 kilogram per meter square (kg\u002Fm\\^2), inclusive, and body weight \\>=45 kg.\n* Negative hepatitis B surface antigen (HBsAg) test\n* Positive hepatitis B surface antibody (HBsAb) test or negative HBsAb\n* Negative HIV (Human Immunodeficiency Virus) test\n* Females will not be pregnant or breastfeeding and must be either postmenopausal or surgically sterile\n* Males will agree to use contraception and will refrain from sperm donation\n\nHealthy participants (Cohort 1):\n\n* Negative hepatitis C virus (HCV) antibody test or positive HCV antibody test followed by a negative HCV RNA test\n* Normal hepatic function and no history of clinically significant hepatic dysfunction\n\nParticipants with Hepatic Impairment (Cohorts 2 and 3):\n\n* Considered to have moderate (Child-Pugh score of 7 to 9) or severe (Child-Pugh score of 10 to 15) hepatic impairment\n* Chronic, stable hepatic insufficiency with features of cirrhosis\n* Negative hepatitis C viral load\n\nExclusion Criteria:\n\nAll participants:\n\n* History of Type 1 diabetes or Type 2 Diabetes that is insulin-dependent or requires ongoing systemic treatment with two or more agents\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder\n* Significant illness, surgery, or hospitalization within 2 weeks prior to dosing.\n* History of gastro-intestinal surgery\n* Malabsorption syndrome or any other condition that would interfere with enteral absorption.\n* History of active or latent Mycobacterium tuberculosis (TB), regardless of treatment history, or positive QuantiFERON® TB Gold test\n* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance\n* Use of drugs of abuse (including opioids)\n\nHealthy participants (Cohort 1):\n\n\\- History of alcoholism or drug addiction\n\nParticipants with Hepatic Impairment (Cohorts 2 and 3):\n\n* Hepatic impairment due to hepatocellular carcinoma or bile duct cancer\n* Surgical or artificial portosystemic shunt (e.g., transjugular intrahepatic portosystemic shunt)\n* Evidence of hepatorenal syndrome\n* Ascites requiring paracentesis\n* Any evidence of progressive liver disease in the last 1 month\n* Receipt of a liver transplant\n* Hepatic encephalopathy Grade 2 or above",true,"ALL","18 Years","80 Years",{"count":94,"type":95},32,"ESTIMATED","INTERVENTIONAL",[98],"PHASE1","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.",[101],"Hepatic Impairment","2026-06-04",{"date":104,"type":105},"2026-06-08","ACTUAL",{"date":107,"type":105},"2025-08-21",{"date":109,"type":95},"2026-09-06",{"name":5,"class":6},4]