Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers
- Registration Number
- NCT03596632
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
The purpose of this study is to determine the excretion kinetics and mass balance of fenebrutinib in healthy male subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Oral Solution Dose Fenebrutinib Single 200-mg (approximately 100-µCi) oral solution dose of \[14C/12C\]-fenebrutinib under fasted conditions.
- Primary Outcome Measures
Name Time Method 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) Screening 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.
- Secondary Outcome Measures
Name Time Method 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 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 Clinical Laboratory Results Screnning, Day -1, 2, 4, 28 Laboratory analysis include chemistry panel, complete blood count and urinalysis.
Maximum Observed Concentration (Cmax) 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) Time to Observed Maximum Concentration (Tmax) 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) Number of Participants With Clinical Significant Changes in Physical Examination Findings Day -1, 28 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.
Number of Participants With Clinical Significant Changes in Electrocardiograms (ECGs) Screening, Day-1, 1 (Pre-dose; 1, 3 hours [h] post-dose), 28, 31 Number of Participants With Clinical Significant Changes in Vital Signs Screening up to Day 31 Vital signs incudes oral temperature, respiratory rate, supine blood pressure and pulse.
Trial Locations
- Locations (1)
Covance Clinical Research Unit, Inc
🇺🇸Madison, Wisconsin, United States