Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

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

Key facts

Study ID

NCT03596632

Run by

Hoffmann-La Roche

People needed

8

Starts

2018-07-27

Expected to finish

2018-08-23

Last updated by the study team

2018-12-06

Who can join

Age: 18 and older, up to 60. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Covance Clinical Research Unit, Inc — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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