Evaluating how divarasib is processed in healthy individuals and those with liver impairment
A Phase 1, Open-Label, Single-Dose, Parallel-Cohort Study to Evaluate the Pharmacokinetics of Divarasib in Subjects With Impaired Hepatic Function
This study is testing how a new drug called divarasib is processed in healthy people compared to those with liver problems to see how liver function affects the medication.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Genentech, Inc. Industry-sponsored |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT06734208 on ClinicalTrials.gov |
What this trial studies
This phase 1, open-label, single-dose, parallel-cohort study aims to assess the pharmacokinetics of divarasib in both healthy participants and those with varying degrees of hepatic impairment, classified by the Child-Pugh score. Participants will receive a single dose of divarasib, and their responses will be monitored to understand how liver function affects the drug's metabolism. The study will include individuals with mild, moderate, or severe hepatic impairment who have been stable for at least one month prior to screening.
Who should consider this trial
Good fit: Ideal candidates include males or females with stable hepatic impairment classified as mild, moderate, or severe by the Child-Pugh score.
Not a fit: Patients with significant history or clinical manifestations of other serious health conditions or those with a QTcF interval exceeding the specified limits may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the safe use of divarasib in patients with liver impairment, potentially improving treatment options for this population.
How similar studies have performed: While this study focuses on a specific drug and population, similar pharmacokinetic studies have shown success in understanding drug metabolism in patients with hepatic impairment.
Eligibility criteria
Show full inclusion / exclusion criteria
Key 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 Key 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
Where this trial is running
Orlando, Florida
- Orlando Clinical Research Center — Orlando, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: GP45713 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.