Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers

NCT ID: NCT03596632

Last Updated: 2018-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-27
• Study Completion Date: 2018-08-23

Brief Summary

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

Conditions

Healthy Participants

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single Oral Solution Dose

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

Group Type: EXPERIMENTAL

Fenebrutinib

Intervention Type: DRUG

200-mg (100 µCi) oral solution 14C/12C\]-fenebrutinib

Interventions

Fenebrutinib

200-mg (100 µCi) oral solution 14C/12C\]-fenebrutinib

Intervention Type: DRUG

Other Intervention Names

RO7010939

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Covance Clinical Research Unit, Inc

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

GP40605

Identifier Type: -

Identifier Source: org_study_id