Lake Forest, CANCT07144111Now EnrollingIRB Ready

Hepatic Impairment Clinical Trial in Lake Forest, CA

Access cutting-edge hepatic impairment treatment through this clinical trial at a research site in Lake Forest. Study-provided care at no cost to qualified participants.

Sponsored by Genentech, Inc.

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Expert Care in Lake Forest

Access hepatic impairment specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related hepatic impairment treatment provided free

Apply for This Lake Forest Location

Check if you qualify for this hepatic impairment clinical trial in Lake Forest, CA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Lake Forest

    Convenient for CA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Lake Forest site if eligible
  4. 4Begin participation

About This Hepatic Impairment Study in Lake Forest

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.

Sponsor: Genentech, Inc.

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Lake Forest?

Yes, this clinical trial (NCT07144111) has an active research site in Lake Forest, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Hepatic Impairment Treatment Options in Lake Forest, CA

If you're searching for hepatic impairment treatment options in Lake Forest, CA, this clinical trial (NCT07144111) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Lake Forest research site is actively enrolling participants for this clinical trial. You'll receive care from experienced hepatic impairment specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all hepatic impairment clinical trials near you to find additional studies recruiting in your area.

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