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Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers
Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers
CompletedPhase 1
Sponsor: Hoffmann-La Roche
Conditions: Healthy Participants
Interventions: Fenebrutinib
Countries: United States
The purpose of this study is to determine the excretion kinetics and mass balance of fenebrutinib in healthy male subjects.
Eligibility overview
Sex: MALE
Age: 18 Years to 60 Years
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Eligibility criteria
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
Locations (1)
- Madison, Wisconsin, United States