Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–80
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
