Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Fenebrutinib

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Oral Solution Dose; Single 200-mg (approximately 100-µCi) oral solution dose of [14C/12C]-fenebrutinib under fasted conditions.	Drug: Fenebrutinib; 200-mg (100 µCi) oral solution 14C/12C]-fenebrutinib; Other Names: RO7010939

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Percentage of the Total Radioactive Dose Administered Excreted from Urine and Feces"; TimeFrame: "Day 1 to end of study (approximately 35 days post-dose)	An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any AE that can be fatal, life threatening, prolongs inpatient hospitalization, significant disability, congenital anamoly, is a significant medical event in the Investigator's judgment.	Screening to end of study (approximately 35 days post-dose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Concentration (Cmax) of Fenebrutinib and its Metabolites		Day 1 pre-dose to end of study (approximately 35 days post-dose)
Time to Observed Maximum Concentration (Tmax) of Fenebrutinib and its Metabolites		Day 1 pre-dose to end of study (approximately 35 days post-dose)
Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) of Fenebrutinib and its Metabolites		Day 1 pre-dose to end of study (approximately 35 days post-dose)
Area under the Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) of Fenebrutinib and its Metabolites		Day 1 pre-dose to end of study (approximately 35 days post-dose)
Cumulative Percent of Total Radioactivity Excreted in Urine Over the Sampling Interval (Total % Feu)		Day 1 pre-dose to end of study (approximately 35 days post-dose)
Cumulative Percent of Total Radioactivity Excreted in Feces Over the Sampling Interval (Total % Fef)		Day 1 pre-dose to end of study (approximately 35 days post-dose)
Number of Participants With Clinical Significant Changes in Vital Signs	Vital signs incudes oral temperature, respiratory rate, supine blood pressure and pulse.	Screening up to Day 31
Number of Participants With Clinical Significant Changes in Physical Examination Findings	Physical examination will consist of an assessment of general appearance, skin, thorax/lungs, abdomen, lymph nodes, head, ears, eyes, nose, throat, neck (including thyroid); and cardiovascular, musculoskeletal, and neurological systems.	Day -1, 28
Number of Participants With Clinical Significant Changes in Clinical Laboratory Results	Laboratory analysis include chemistry panel, complete blood count and urinalysis.	Screnning, Day -1, 2, 4, 28
Number of Participants With Clinical Significant Changes in Electrocardiograms (ECGs)		Screening, Day-1, 1 (Pre-dose; 1, 3 hours [h] post-dose), 28, 31

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2018
• Primary Completion (Actual): August 23, 2018
• Study Completion (Actual): August 23, 2018

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: July 13, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 5, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: GP40605

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No