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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants with normal hepatic function will receive a single oral dose of inavolisib on Day 1 |
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| Cohort 2 | Experimental | Participants with moderate hepatic function will receive a single oral dose of inavolisib on Day 1 |
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| Cohort 3 | Experimental | Participants with severe hepatic function will receive a single oral dose of inavolisib on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inavolisib | Drug | Participants will receive a single oral dose of inavolisib |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Inavolisib | 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 | 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 | 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 | 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 | 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 | Pre-dose (0 hour), 30 minutes (min), 1, 1.5, 2, 3, 4, 6, 8, 10, 24, 48, 72, and 96 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) | From Baseline up to Follow-up (Day 8) |
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Inclusion Criteria:
All participants:
Healthy participants (Cohort 1):
Participants with Hepatic Impairment (Cohorts 2 and 3):
Exclusion Criteria:
All participants:
Healthy participants (Cohort 1):
- History of alcoholism or drug addiction
Participants with Hepatic Impairment (Cohorts 2 and 3):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reference Study ID Number: GP45942 https://forpatients.roche.com/ No attachments to email below. | Contact | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com | |
| Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Recruiting | Lake Forest | California | 92630 | United States | |
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| Label | URL |
|---|---|
| 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. | View source |
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| ID | Term |
|---|---|
| C000723546 | inavolisib |
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| Orlando Clinical Research Center |
| Recruiting |
| Orlando |
| Florida |
| 32809 |
| United States |
| The Texas Liver Institute, Inc. | Recruiting | San Antonio | Texas | 78215 | United States |
| Pinnacle Clinical Research - San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |