A Study to Evaluate the Pharmacokinetics of Divarasib in Healthy Participants and Participants With Impaired Hepatic Function

Launched by GENENTECH, INC. · Dec 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called divarasib to see how it is processed in the body, especially in people with liver problems. The study is open to both healthy individuals and those with varying levels of liver impairment, which doctors classify using a system called the Child-Pugh score. The goal is to understand how the medication behaves in people with mild, moderate, or severe liver issues compared to healthy participants.

To be eligible for this trial, participants should be men or women who are not pregnant and have a healthy body weight. Those with liver impairment must have been stable for at least a month prior to joining the study. Participants can expect to receive a single dose of divarasib and will be monitored for how their bodies react to it. It's important to note that individuals with certain serious health conditions or recent liver complications may not be able to participate. This study is currently recruiting volunteers aged between 18 and 74, regardless of gender.

Gender

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Eligibility 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