NCT07144111 A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib
| NCT ID | NCT07144111 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Genentech, Inc. |
| Condition | Hepatic Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-08-21 |
| Primary Completion | 2026-09-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2025-08-21 with a primary completion date of 2026-09-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Reference Study ID Number: GP45942 https://forpatients.roche.com/ No attachments to email below.
✉ global-roche-genentech-trials@gene.com📞 888-662-6728 (U.S. and Canada)
Clinical Trials
STUDY DIRECTOR
Genentech, Inc.
Frequently Asked Questions
Who can join the NCT07144111 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hepatic Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07144111 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07144111 currently recruiting?
Yes, NCT07144111 is actively recruiting participants. Contact the research team at global-roche-genentech-trials@gene.com for enrollment information.
Where is the NCT07144111 trial being conducted?
This trial is being conducted at Lake Forest, United States, Orlando, United States, San Antonio, United States, San Antonio, United States.
Who is sponsoring the NCT07144111 clinical trial?
NCT07144111 is sponsored by Genentech, Inc.. The principal investigator is Clinical Trials at Genentech, Inc.. The trial plans to enroll 32 participants.