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

  • Hepatitis B Virus
  • Liver Failure
Trial Status:

Completed

This trial runs in
Countries
  • United States
Trial Identifier:

NCT03341884 GP40200

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      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.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT03341884 , GP40200 Trial Identifier
      Ipatasertib Treatments
      Hepatic Insufficiency Condition
      Official Title

      A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Ipatasertib in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Subjects

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 74 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria
      • 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
      Exclusion Criteria
      • 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

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