Clinical trial NCT03596632: Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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


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

Primary outcomes:
measure: 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)
timeFrame: Screening to end of study (approximately 35 days post-dose)
Secondary outcomes:
measure: Maximum Observed Concentration (Cmax) of Fenebrutinib and its Metabolites
timeFrame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
measure: Time to Observed Maximum Concentration (Tmax) of Fenebrutinib and its Metabolites
timeFrame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
measure: Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) of Fenebrutinib and its Metabolites
timeFrame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
measure: Area under the Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) of Fenebrutinib and its Metabolites
timeFrame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
measure: Cumulative Percent of Total Radioactivity Excreted in Urine Over the Sampling Interval (Total % Feu)
timeFrame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
measure: Cumulative Percent of Total Radioactivity Excreted in Feces Over the Sampling Interval (Total % Fef)
timeFrame: Day 1 pre-dose to end of study (approximately 35 days post-dose)
measure: Number of Participants With Clinical Significant Changes in Vital Signs
timeFrame: Screening up to Day 31
measure: Number of Participants With Clinical Significant Changes in Physical Examination Findings
timeFrame: Day -1, 28
measure: Number of Participants With Clinical Significant Changes in Clinical Laboratory Results
timeFrame: Screnning, Day -1, 2, 4, 28
measure: Number of Participants With Clinical Significant Changes in Electrocardiograms (ECGs)
timeFrame: Screening, Day-1, 1 (Pre-dose; 1, 3 hours [h] post-dose), 28, 31
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit, Inc
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: