A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian Participants

  • Healthy Volunteers
Trial Status:

Completed

This trial runs in
Countries
  • United States
Trial Identifier:

NCT03188783 GP39851

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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 investigate the safety, tolerability, and pharmacokinetics of single and multiple oral doses of GDC-0853 in healthy Japanese and Caucasian subjects.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT03188783 , GP39851 Trial Identifier
      GDC-0853, Placebo Treatments
      Healthy Volunteer Condition
      Official Title

      A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GDC-0853 in Healthy Japanese and Caucasian Subjects

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 55 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria
      • Japanese subjects must have both Japanese parents and all grandparents who were born in a Japanese country of origin
      • Caucasian subjects must have 4 Caucasian grandparents (Hispanics of white race can be considered Caucasians)
      • Within body mass index range of 18 to 31 kilograms per square meter, inclusive
      • Females will be non-pregnant, non-lactating, and either postmenopausal or surgically sterile
      • Males will either be sterile or agree to use an approved method of contraception
      Exclusion Criteria
      • Significant history or clinical manifestation of any significant metabolic, allergic/immunologic/immunodeficiency, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the investigator)
      • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
      • Participation in any other investigational study drug trial in which receipt of any investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to check in
      • History of malignancy, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma with 3-year disease-free follow up
      • Any acute or chronic condition or any other reason that, in the opinion of the investigator, would limit the participant's ability to complete and/or participate in this clinical study

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