Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib

  • Liver Failure
Trial Status:

Completed

This trial runs in
Countries
  • Czechia
  • Slovakia
Trial Identifier:

NCT02621047 2015-002976-25 NP29783

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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 multicenter, non-randomized, single-dose, open-label study conducted in male and surgically sterile or post-menopausal female participants with stable chronic hepatic impairment and in healthy participants matched by age, gender, and body weight to assess the effect of hepatic impairment on the pharmacokinetics of alectinib.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT02621047 , NP29783 , 2015-002976-25 Trial Identifier
      Alectinib Treatments
      Hepatic Impairment Condition
      Official Title

      The Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib: A Multiple-Center, Open-Label Study Following Single Oral Dosing of Alectinib to Subjects With Hepatic Impairment and Matched Healthy Subjects With Normal Hepatic Function

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 70 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria

      All Participants

      • Body mass index between 18 to 35 kilograms per square meter (kg/m^2) inclusive and weight greater than (>) 50 kilograms (kg)
      • Female participants must be surgically sterile or post-menopausal
      • Male participants and their partners of child-bearing potential must be willing to use 2 effective methods of contraception, one of which must be a barrier method

      Participants with Hepatic Impairment

        - Documented chronic stable liver disease (Child-Pugh Class A, B or C)
      Exclusion Criteria

      All Participants

      • Pregnant or lactating women, males with female partners who are pregnant or lactating, or women of child bearing potential
      • Positive test for drugs of abuse or alcohol
      • Participation in an investigational drug or device study within 45 days or 5 half-lives (whichever time period is longer) or 6 months for biologic therapies prior to study drug administration
      • History of hypersensitivity to any of the additives in the alectinib formulation
      • Participants under judicial supervision, guardianship, or curatorship
      • History of severe drug-related allergic reactions or drug-induced hepatotoxicity

      Healthy Participants

      • Use of any medications (prescription or over-the-counter), within 2 weeks or 5 half-lives (whichever longer) prior to study drug administration
      • Use of any herbal supplements or any metabolic inducers within 4 weeks, or 5 half-lives (whichever is longer) prior to study drug administration

      Participants with Hepatic Impairment

      • Positive screening test for human immunodeficiency virus (HIV)
      • History of liver transplantation
      • Hepatocellular carcinoma or acute liver disease
      • Severe ascites at screening or admission to the clinic
      • Recent history (past 2 years) or current severe hepatic encephalopathy (Grade 3 or higher)
      • Any evidence of progressive liver disease within the last 4 weeks
      • Presence of surgically created or transjugular intrahepatic portal systemic shunts

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