Hepatic ImpairmentPhase 1NCT07144111
A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib
A Phase 1 study testing Inavolisib in people with Hepatic Impairment, run by Genentech, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment
- What is being tested?
- Inavolisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Aug 2025to 13 Oct 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Orange County Research Center
Lake Forest, California, 92630
Orlando Clinical Research Center
Orlando, Florida, 32809-3017
The Texas Liver Institute, Inc.
San Antonio, Texas, 78215
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics of Inavolisib
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.
- Conditions
- Hepatic Impairment
- Being tested
- Inavolisib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InavolisibDrug
Participants will receive a single oral dose of inavolisib
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants with normal hepatic function will receive a single oral dose of inavolisib on Day 1 Receives: Drug: Inavolisib |
| Cohort 2 | Experimental | Participants with moderate hepatic function will receive a single oral dose of inavolisib on Day 1 Receives: Drug: Inavolisib |
| Cohort 3 | Experimental | Participants with severe hepatic function will receive a single oral dose of inavolisib on Day 1 Receives: Drug: Inavolisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Concentration (Cmax) of Inavolisib
Measured: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Area Under Curve (AUC) from Hour 0 to the Last Measurable Concentration (AUC [0-t]) of Inavolisib
Measured: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
AUC from Zero to Infinity (AUC [0-inf]) Extrapolated of Inavolisib
Measured: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Geometric Mean Ratio of Cmax of Inavolisib
Measured: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Geometric Mean Ratio of AUC (0-t) of Inavolisib
Measured: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Geometric Mean Ratio of AUC (0-inf) of Inavolisib
Measured: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Secondary outcomes (1)
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured: From Baseline up to Follow-up (Day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start21 Aug 2025
- Primary completion13 Oct 2026
- Study completion13 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144111
- Sponsor's protocol ID
- GP45942
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single-Dose Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics of Inavolisib
- ClinicalTrials.gov ID
- NCT07144111
- Acronym / sponsor ID
- GP45942
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 13 Oct 2026 (actual)
- Study completion
- 13 Oct 2026 (actual)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: InavolisibParticipants with normal hepatic function will receive a single oral dose of inavolisib on Day 1 |
| Cohort 2 | Experimental | Drug: InavolisibParticipants with moderate hepatic function will receive a single oral dose of inavolisib on Day 1 |
| Cohort 3 | Experimental | Drug: InavolisibParticipants with severe hepatic function will receive a single oral dose of inavolisib on Day 1 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InavolisibParticipants will receive a single oral dose of inavolisib | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Maximum Observed Concentration (Cmax) of Inavolisib
Time frame: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Area Under Curve (AUC) from Hour 0 to the Last Measurable Concentration (AUC [0-t]) of Inavolisib
Time frame: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
AUC from Zero to Infinity (AUC [0-inf]) Extrapolated of Inavolisib
Time frame: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Geometric Mean Ratio of Cmax of Inavolisib
Time frame: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Geometric Mean Ratio of AUC (0-t) of Inavolisib
Time frame: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
Geometric Mean Ratio of AUC (0-inf) of Inavolisib
Time frame: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose
1 secondary outcome
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: From Baseline up to Follow-up (Day 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Inavolisib in people with Hepatic Impairment, run by Genentech, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Concentration (Cmax) of Inavolisib (time frame: Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.