A Study to Evaluate the Pharmacokinetics of Divarasib in Healthy Participants and Participants With Impaired Hepatic Function

  • Metabolic Disorder
  • Liver Failure
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Not yet recruiting

This trial runs in
N/A
Trial Identifier:

NCT06734208 GP45713

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      This is a phase 1, open-label, single-dose, parallel-cohort study to determine the pharmacokinetics (PK) of divarasib in healthy participants and participants with varying degrees of hepatic impairment, as defined by Child-Pugh classification.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT06734208, GP45713 Trial Identifier
      Divarasib Treatments
      Hepatic Impairment Condition
      Official Title

      A Phase 1, Open-Label, Single-Dose, Parallel-Cohort Study to Evaluate the Pharmacokinetics of Divarasib in Subjects With Impaired Hepatic Function

      Eligibility Criteria

      All Gender
      ≥18 Years & ≤ 80 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria
      • 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
      Exclusion Criteria
      • 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
      • Hepatic encephalopathy Grade 2 or above

      For the latest version of this information please go to www.forpatients.roche.com

       

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