A Clinical Trial to Investigate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein and Breast Cancer Resistance Protein in Healthy Participants

  • Cancer
  • Solid Tumors
  • Healthy Volunteers
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Completed

This study runs in
Country
  • United States
Study Identifier:

NCT06677957 GP45712

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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 study 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

      Study Summary

      This is a Phase 1, open-label, two-period, one-sequence, crossover drug-drug interaction study to assess the P-gp and BCRP inhibition potential of divarasib using digoxin and rosuvastatin as probe substrates, respectively, in healthy participants.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT06677957, GP45712 Study Identifier
      Digoxin, Divarasib, Rosuvastatin Treatments
      Healthy Participants Condition
      Official Title

      A Phase I, Open-Label, Two-Period, One-Sequence, Crossover Study in Healthy Subjects to Evaluate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein (Digoxin) and Breast Cancer Resistance Protein (Rosuvastatin)

      Eligibility Criteria

      All Gender
      ≥18 Years & ≤ 60 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 32.0 kg/m2, inclusive
      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
      • Poor peripheral venous access

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

       

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