Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Fenebrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03596632

GP40605

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Single Oral Solution Dose

Experimental group

Description:

Single 200-mg (approximately 100-µCi) oral solution dose of \[14C/12C\]-fenebrutinib under fasted conditions.

Treatment:

Drug: Fenebrutinib