Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–74
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Females will not be pregnant or breastfeeding, and must be either postmenopausal or agree to use a study-approved method of contraception from the time of signing the informed consent until 30 days after discharge
Males will either be sterile or agree to use male condom with spermicide from check-in (Day -1) until 90 days following the dose of study drug
\- Liver enzyme tests must be less than or equal to the upper limits of normal
You may not be if
\- Hepatic impairment must have a Child-Pugh score of 5 to 6 (mild), 7 to 9 (moderate), or 10 to 15 (severe) and have stable hepatic insufficiency within 1 month prior to Screening
History of ulcerative colitis or stomach or intestinal surgery or resection
History of unstable diabetes mellitus
History of alcoholism or drug addiction within 1 year prior to Check-in (Day -1)
Use of oral, implantable, transdermal, or injectable contraceptives from the time of signing the informed consent (females only) or 10 days prior to Check-in through 45 days after the dose administration
Poor peripheral venous access
Receipt of blood products within 2 months prior to check-in
Use of any tobacco- or nicotine-containing products within 6 months prior to check-in and during the entire study
Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
Any evidence of progressive liver disease that has worsened or is worsening within 1 month prior to the screening visit
Participant has shown evidence of hepatorenal syndrome
Ascites requiring paracentesis
Participant has required treatment for GI bleeding within 12 months prior to Check-in
Participant has required additional medication for hepatic encephalopathy within the 12 months (6 months for severe hepatic impairment) prior to check-in
Total bilirubin levels \>6 mg/dL
Clareo Health | A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants
