A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants

Completed · Phase 1

Conditions studied: Hepatic Insufficiency

In brief

This is a Phase 1 study evaluating the pharmacokinetics, tolerability and safety of a single dose of ipatasertib in participants with mild, moderate or severe hepatic impairment compared to healthy participants.

Key facts

Study ID

NCT03341884

Run by

Genentech, Inc.

People needed

29

Starts

2017-11-09

Expected to finish

2018-06-26

Last updated by the study team

2019-11-18

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• In good health (except for specific inclusion criteria related to hepatic impairment), as determined by the Investigator, based on no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram, and vital signs
• 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
• Additional Inclusion Criteria for Healthy Subjects Only:
• Liver enzyme tests must be less than or equal to the upper limits of normal
• Additional Exclusion Criteria for Hepatic Impaired Subjects Only:
• 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

You may not qualify if…

• 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
• Additional Exclusion Criteria for Healthy Subjects Only:
• 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
• Additional Exclusion Criteria for Hepatic Impaired Subjects Only:
• 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

Where it is running

• Clinical Pharmacology of Miami, Inc. — Miami, Florida, United States
• New Orleans Center for Clinical Research — Knoxville, Tennessee, United States
• American Research Corporation Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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