Study Investigating a Single Oral Dose of Fenebrutinib in Healthy Volunteers

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03596632
• Other study ID #: GP40605
• Status: Completed
• Phase: Phase 1
• Start date: July 27, 2018
• Est. completion date: August 23, 2018

Study information

• Verified date: December 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 23, 2018
• Est. primary completion date: August 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Fenebrutinib
200-mg (100 µCi) oral solution 14C/12C]-fenebrutinib

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit, Inc	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum Observed Concentration (Cmax) of Fenebrutinib and its Metabolites		Day 1 pre-dose to end of study (approximately 35 days post-dose)
Secondary	Time to Observed Maximum Concentration (Tmax) of Fenebrutinib and its Metabolites		Day 1 pre-dose to end of study (approximately 35 days post-dose)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants With Clinical Significant Changes in Electrocardiograms (ECGs)		Screening, Day-1, 1 (Pre-dose; 1, 3 hours [h] post-dose), 28, 31