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Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers
- Healthy Volunteers
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Country
- United States
Trial Identifier:
NCT03596632 GP40605
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
For the latest version of this information please go to www.forpatients.roche.com