A Study to Evaluate the Pharmacokinetics of Divarasib in Healthy Participants and Participants With Impaired Hepatic Function
Purpose
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.
Condition
- Hepatic Impairment
Eligibility
- Eligible Ages
- Between 18 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Males or females of non-childbearing potential - Within body mass index (BMI) range of 18.0 to 45.0 kg/m2 Participants with Hepatic Impairment - Considered to have mild, moderate, or severe hepatic impairment by Child-Pugh Score classification and has been clinically stable for at least 1 month prior to Screening - Chronic (>6 months), stable hepatic insufficiency with features of cirrhosis due to any etiology. Participants must also remain stable throughout the Screening period
Exclusion Criteria
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder - History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator Participants with Hepatic Impairment - Have a QTcF >480 msec for males and >490 msec for females at Screening or Check-in. If any parameter is out of range, the ECG may be repeated for confirmation - Any evidence of progressive liver disease that has worsened or is worsening, as determined by the investigator, within 1 month prior to Screening - Demonstrated evidence of hepatorenal syndrome - Ascites requiring paracentesis or other intervention up to 3 days prior to the study - Hepatic encephalopathy Grade 2 or above
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort 1 |
Participants will receive a single oral dose of Divarasib on Day 1. |
|
|
Experimental Cohort 2 |
Participants will receive a single oral dose of Divarasib on Day 1. |
|
|
Experimental Cohort 3 |
Participants will receive a single oral dose of Divarasib on Day 1. |
|
|
Experimental Cohort 4 |
Participants will receive a single oral dose of Divarasib on Day 1. |
|
Recruiting Locations
More Details
- NCT ID
- NCT06734208
- Status
- Completed
- Sponsor
- Genentech, Inc.