A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants

  • Healthy Volunteers
Trial Status:

Completed

This trial runs in
Countries
  • United Kingdom
Trial Identifier:

NCT03290703 2017-000752-26 GP39619

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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

      The purpose of this study is to evaluate the PK of GDC-0853 following changes to formulation and in the presence or absence of food, the proton pump inhibitor (rabeprazole), or both. This will be a 3-part open-label randomized study conducted in healthy adult participants. Approximately 63 subjects will be enrolled in this study.

      Genentech, Inc. Sponsor
      Phase 1 Phase
      NCT03290703 , GP39619 , 2017-000752-26 Trial Identifier
      GDC-0853, Rabeprazole Treatments
      Healthy Volunteers Condition
      Official Title

      A Phase I, Single Center, Randomized, Open-Label Study Investigating the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics of GDC-0853 in Healthy Subjects

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 65 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria
      • Healthy male or female (of non-childbearing potential) participants
      • Within body mass index range 18.0 to 32.0 kilogram per meter square (kg/m^2), inclusive
      • In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs and physical examinations
      • For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
      Exclusion Criteria
      • History or symptoms of any significant disease
      • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
      • History of stomach or intestinal surgery or resection
      • Participants who previously participated in any other investigational study drug trial within 90 days prior to Check-in. Participants who previously received GDC-0853 in previous studies.
      • History of malignancy
      • Pregnancy, lactation, or breastfeeding in female participants

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