Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase 1, open-label, single-dose, parallel-cohort study to determine the pharmacokinetics (PK) of divarasib in healthy participants and participants with varying degrees of hepatic impairment, as defined by Child-Pugh classification.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive a single oral dose of Divarasib on Day 1. |
|
| Cohort 2 | Experimental | Participants will receive a single oral dose of Divarasib on Day 1. |
|
| Cohort 3 | Experimental | Participants will receive a single oral dose of Divarasib on Day 1. |
|
| Cohort 4 | Experimental | Participants will receive a single oral dose of Divarasib on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Divarasib | Drug | Divarasib will be administered as a single oral dose as specified for the respective cohort. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of Divarasib | Day 1 to Day 7 | |
| Maximum Observed Concentration (Cmax) of Divarasib | Day 1 to Day 7 | |
| Area Under the Concentration-time Curve from Hour 0 to the last measurable concentration (AUC0-t) of Divarasib | Day 1 to Day 7 | |
| Area Under the Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Divarasib | Day 1 to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) | Up to Week 10 |
Not provided
Key Inclusion Criteria
Participants with Hepatic Impairment
Key Exclusion Criteria
Participants with Hepatic Impairment
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, Inc. | Miami | Florida | 33014 | United States | ||
| Panax Clinical Research, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Miami Lakes |
| Florida |
| 33014 |
| United States |
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| American Research Corporation Inc. | San Antonio | Texas | 78215 | United States |