Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers

  • Healthy Volunteers
Trial Status:

Completed

This trial runs in
Cities
  • Madison
Trial Identifier:

NCT03596632 GP40605

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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.

      Results Disclaimer

      Trial Summary

      The purpose of this study is to determine the excretion kinetics and mass balance of fenebrutinib in healthy male subjects.

      Hoffmann-La Roche Sponsor
      Phase 1 Phase
      NCT03596632 , GP40605 Trial Identifier
      Fenebrutinib Treatments
      Healthy Participants Condition
      Official Title

      A Phase 1 Open-label Study Investigating the Excretion Balance, Pharmacokinetics, and Metabolism of a Single Oral Dose of [14C/12C]-Labeled Fenebrutinib in Healthy Volunteers

      Eligibility Criteria

      Male Gender
      ≥ 18 Years & ≤ 60 Years Age
      Accepts Healthy Volunteers Healthy Volunteers
      Inclusion Criteria
      • Healthy male subjects, between 18 and 60 years of age, inclusive
      • Within body mass index range 18 to 32 kg/m2, inclusive
      • In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG), vital signs, and physical examination
      • For males who are sterile: agreement to use a condom with a fertile or pregnant female partner from Day -1 until 90 days following Study Completion; for males who are fertile: agreement to use a condom with spermicide with a fertile or pregnant female partner from Day -1 until 90 days following Study Completion
      Exclusion Criteria
      • History or symptoms of any significant disease
      • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator
      • History of stomach or intestinal surgery or resection, except appendectomy, hernia repair, and cholecystectomy
      • History of malignancy, except for non-melanoma skin carcinoma with 3-year disease-free follow-up
      • Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to Day -1
      • Exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Day -1
      • Participation in a radiolabeled drug study in which exposures are known to the Investigator within 4 months prior to Day -1, or participation in a radiolabeled drug study in which exposures are not known to the Investigator within 6 months prior to Day -1. The total 12-month exposure from this study and a maximum of 2 other studies must be within the Code of Federal Regulations (CFR) recommended levels considered state (per 21 CFR 361.1), e.g. less than 5,000 mrem whole body annual exposure

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